Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, sterile FDA UDI
- Device Name
- HVY-DTY BK TAB CVR, 70 IN. X 110 IN177 CM X 279 CM FDA UDI
- Model / Reference
- 42309 FDA UDI
- Description
- HVY-DTY BK TAB CVR, 70 IN. X 110 IN177 CM X 279 CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10680651423099 FDA UDI
- 510(k) Number
- K083234 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, sterile 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument/equipment drape, single-use, sterile
Halyard by O&M Halyard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument/equipment drape, single-use, sterile.
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Cleared under the same submission
K083234 also covers:
- HYH — O&M HALYARD, INC.
- HYH — 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 a25e28c1-68be-46dc-9310-5421276d7669 35 fields · synced Jun 8, 2026