Identity
- Trade Name
- Y-KNOT ONESTEP FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Y-Knot OneStep Guide, Fishmouth, Disposable FDA UDI
- Model / Reference
- Y1SG1D FDA UDI
- Description
- Y-Knot OneStep Guide, Fishmouth, Disposable FDA UDI
Identifiers
- Catalog Number
- Y1SG1D FDA UDI
- Primary DI / UDI-DI
- 20845854649135 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical drill guide, single-use
Y-Knot Onestep by Conmed Corporation — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI 1f205fad-1666-4ea0-b1d1-7f9056bcaf87 36 fields · synced Jun 1, 2026