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510(k) Data Aggregation
K Number
K102783Device Name
HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
Manufacturer
Date Cleared
2010-12-22
(86 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
HINSON AND HALE MEDICAL TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158, are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device up until 30 days. The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158. are provided non-sterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum, 270oF, 4 minutes with 20 minutes drying time).
Device Description
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K Number
K094016Device Name
NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H
Manufacturer
Date Cleared
2010-11-19
(325 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
HINSON AND HALE MEDICAL TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towels, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR17X27WB), are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The OR towels are further used as a fluid absorbing towel during surgery or as a device to dry the hands of OR personnel. These towels are provided non-sterile and must be processed before use. These towels may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum sterilizer, 270°F, 4 minutes with 20 minutes drying time).
Device Description
Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towel, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR17X27WB).
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