KENPAX INTERNATIONAL LIMITED

Address:Flat 5, 5/F., Wing On Plaza,Kowloon,HK

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Accessory, Surgical Apparel (LYU) (1)

Premarket Exempt

Yes No

Clear

SURGIPLUS - 74895237141535 Catalog Number : 68-6149-B

Device Description : Warm-up Jacket, Blue, XLA non-sterile garment designed to be worn by healthcare Warm-up Jacket, Blue, XLA non-sterile garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically a shirt composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

Device Class : 1

Duns Number: 686206765

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

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