Identity
- Trade Name
- Professional Surgical Instruments Co., Inc. FDA UDI
- Generic Name
- Suturing needle holder, single-use FDA UDI
- Device Name
- 5" Webster Needle Holder, Satin FDA UDI
- Model / Reference
- S14-207 FDA UDI
- Description
- 5" Webster Needle Holder, Satin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853863007347 FDA UDI
- FDA Product Code
- FHQ FDA UDI
- GMDN Term
- Suturing needle holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Suturing needle holder, single-use
Professional Surgical Instruments Co., Inc. by Professional Surgical Instruments Co., Inc. — Class I — FDA UDI — listed in FDA GUDID
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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
- Professional Surgical Instruments Co., Inc.
Sources (1)
- FDA UDI 08679778-12b0-4ae6-a4d3-fdd859756a87 33 fields · synced Jun 8, 2026