Identity
- Trade Name
- Greenwald Surgical Company, Inc. FDA UDI
- Generic Name
- Gynaecological cerclage needle FDA UDI
- Device Name
- Orandi Resectoscope Injection Needle FDA UDI
- Model / Reference
- 51850-00 FDA UDI
- Description
- Orandi Resectoscope Injection Needle FDA UDI
Identifiers
- Catalog Number
- U267 FDA UDI
- Primary DI / UDI-DI
- 10801334001551 FDA UDI
- FDA Product Code
- FBK FDA UDI
- GMDN Term
- Gynaecological cerclage needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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: Gynaecological cerclage needle
Greenwald Surgical Company, Inc. by Grace Manufacturing Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gynaecological cerclage needle.
- PILLING — TELEFLEX INCORPORATED · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class II
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 f0143bd5-ef8d-43bc-b1e0-e884bb12c7ff 34 fields · synced Jun 1, 2026