Identity
- Trade Name
- PremierPro FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- PremierPro Disposable Lab Jacket Knit Collar and Cuff, Blue, Small, 5/bg FDA UDI
- Model / Reference
- 2712 FDA UDI
- Description
- PremierPro Disposable Lab Jacket Knit Collar and Cuff, Blue, Small, 5/bg FDA UDI
Identifiers
- Catalog Number
- 2712 FDA UDI
- Primary DI / UDI-DI
- 00818566013231 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Isolation gown, 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Isolation gown, single-use
The PremierPro Disposable Lab Jacket Knit Collar and Cuff is a versatile and practical isolation gown designed for healthcare professionals, providing protection from infectious agents and contamination. With its durable construction and comfortable fit, this product is ideal for surgical procedures, laboratory settings, and other high-risk environments.
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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
- Svs Llc
Sources (1)
- FDA UDI 1a70c62c-3b0f-4f8b-b3a6-959214c5c896 35 fields · synced Jul 23, 2026