Identity
- Trade Name
- AnchorKnot Suture Passer (2-0) FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Model / Reference
- PSZ-400-305 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540299000136 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
AnchorKnot Suture Passer (2-0) by Baylis Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Baylis Medical Technologies Inc
Sources (1)
- FDA UDI 5bca6e32-f863-4e5b-bfcb-d2c68fd3fd41 34 fields · synced May 30, 2026