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510(k) Data Aggregation
K Number
K080448Device Name
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
Manufacturer
TRI-STATE HOSPITAL SUPPLY CORP.
Date Cleared
2008-08-28
(191 days)
Product Code
FMQ, FMO
Regulation Number
880.6760Why did this record match?
Applicant Name (Manufacturer) :
TRI-STATE HOSPITAL SUPPLY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Centurion® Protective Restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting.
The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.
Device Description
The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyester foam core, and nylon tricot backing.
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K Number
K080524Device Name
CENTURION SORBAVIEW OTC
Manufacturer
TRI-STATE HOSPITAL SUPPLY CORP.
Date Cleared
2008-04-23
(57 days)
Product Code
FRO, KGX
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRI-STATE HOSPITAL SUPPLY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Centurion® SorbaView® OTC dressings are intended for medical purposes to cover and protect wounds, hold together the skin edges of a wound, support an injured part of the body, or to secure objects to the skin.
This device is intended for lay or prescription use by pediatric or adult patients.
Device Description
Sorba View® dressings are highly permeable, self-adhesive, transparent film dressings that are of multi-layer construction. The multi-layer construction consists of:
- Polyurethane film, .
- . Solvent-spun cellulose,
- . Medical grade adhesive,
- ◆ Non-woven fabric, and
- Kraft liner with silicone release coating. .
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