Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- ULTRA SURGICAL GOWN WITH TOWEL IN OVERWRAP, NON-STERILE, X-LARGE, HANDI-BIN FDA UDI
- Model / Reference
- 39715 FDA UDI
- Description
- ULTRA SURGICAL GOWN WITH TOWEL IN OVERWRAP, NON-STERILE, X-LARGE, HANDI-BIN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10680651397154 FDA UDI
- 510(k) Number
- K080795 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, single-use 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical gown, single-use
Halyard by O&M Halyard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080795 also covers:
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
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
- O&M Halyard, Inc.
Sources (1)
- FDA UDI 1a1ee79d-2f1e-459d-845b-7237d6afd66e 35 fields · synced May 30, 2026