Identity
- Trade Name
- Essentials FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- Isolation Gowns AAMI 3 Blue Medium FDA UDI
- Model / Reference
- 5702385 FDA UDI
- Description
- Isolation Gowns AAMI 3 Blue Medium FDA UDI
Identifiers
- Catalog Number
- 5702385 FDA UDI
- Primary DI / UDI-DI
- 10304040140410 FDA UDI
- FDA Product Code
- FYC FDA UDI
- GMDN Term
- Isolation gown, reusable FDA UDI
Classification
- Device Class
- Class II 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, reusable
Essentials by Henry Schein, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein, Inc.
Sources (1)
- FDA UDI 66dc79b2-3d34-4220-94d1-92f397d95c66 35 fields · synced Jun 8, 2026