Identity
- Trade Name
- Greenwald Surgical Company, Inc. FDA UDI
- Generic Name
- Suturing needle, reusable FDA UDI
- Device Name
- Rebuilt no-slip tip urethral suture guide FDA UDI
- Model / Reference
- 58958-28 FDA UDI
- Description
- Rebuilt no-slip tip urethral suture guide FDA UDI
Identifiers
- Catalog Number
- U515R FDA UDI
- Primary DI / UDI-DI
- 10801334013493 FDA UDI
- FDA Product Code
- FFL FDA UDI
- GMDN Term
- Suturing needle, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suturing needle, reusable
Greenwald Surgical Company, Inc. by Grace Manufacturing Inc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Grace Manufacturing Inc
Sources (1)
- FDA UDI 186e9240-f2e3-4404-a628-797603f928cb 35 fields · synced May 30, 2026