Identity
- Trade Name
- Single-Use Biopsy Forceps FDA UDI
- Generic Name
- Endometrial biopsy kit FDA UDI
- Model / Reference
- RP-U-P16F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936937712997 FDA UDI
- FDA Product Code
- FCL FDA UDI
- GMDN Term
- Endometrial biopsy kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1075 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endometrial biopsy kit
Single-Use Biopsy Forceps by Jiangsu Grit Medical Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endometrial biopsy kit.
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- Patel Pipelle — TITUS MEDICAL LLC · Class II
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
- Echosampler — Gynetics Medical Products NV · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- Suresample, Endometrial Sampler — GYNEX CORPORATION · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Grit Medical Technology Co., Ltd.
Sources (1)
- FDA UDI d5c3e732-7677-448f-8528-cc514b2ded07 32 fields · synced May 30, 2026