Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- HALYARD* ULTRA* SMS & Film Surgical Gown, Zoned Impervious-XX-Large-Handi-Bin-384 FDA UDI
- Model / Reference
- 13229 FDA UDI
- Description
- HALYARD* ULTRA* SMS & Film Surgical Gown, Zoned Impervious-XX-Large-Handi-Bin-384 FDA UDI
Identifiers
- Catalog Number
- 13229NS FDA UDI
- Primary DI / UDI-DI
- 20680651132295 FDA UDI
- 510(k) Number
- K842115 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
K842115 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 3143c73f-0ed3-4ad7-8e15-a7af9975a31e 36 fields · synced May 30, 2026