Identity
- Trade Name
- NEEDLES 25x1 FDA UDI
- Generic Name
- Medication cartridge syringe, safety-needle FDA UDI
- Device Name
- NEEDLES 25x1 FDA UDI
- Model / Reference
- 11-251 FDA UDI
- Description
- NEEDLES 25x1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00369771001846 FDA UDI
- 510(k) Number
- K193526 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Medication cartridge syringe, safety-needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medication cartridge syringe, safety-needle
NEEDLES 25x1 by Geri-Gentle Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medication cartridge syringe, safety-needle.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Doctors Choice — Supply Line International Medical, LLC · Class II
- Artman Instruments — WISE LINKERS LLC · Class II
- Doctors Choice — Supply Line International Medical, LLC · Class II
- Doctors Choice — Supply Line International Medical, LLC · Class II
- Artman Instruments — WISE LINKERS LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Artman Instruments — WISE LINKERS LLC · Class II
Cleared under the same submission
K193526 also covers:
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- NEEDLES 23x1 — GERI-GENTLE CORPORATION
- NEEDLES 25x5/8 — GERI-GENTLE CORPORATION
- CAINA — Jiangsu Caina Medical Co., Ltd
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Geri-Gentle Corporation
Sources (1)
- FDA UDI a6c3f61b-db35-4e50-9541-0decce704a0a 34 fields · synced May 30, 2026