Identity
- Trade Name
- SURGIPLUS FDA UDI
- Generic Name
- Scrub suit, single-use FDA UDI
- Device Name
- Scrub Shirt, L A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Scrub Shirt, L A non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants 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. FDA UDI
Identifiers
- Catalog Number
- 68-7171-B FDA UDI
- Primary DI / UDI-DI
- 74895237108019 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Scrub suit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scrub suit, single-use
Surgiplus by Kenpax International Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kenpax International Limited
Sources (1)
- FDA UDI cee441a5-2aa4-4eca-97a1-675f4068fae0 34 fields · synced May 30, 2026