Identity
- Trade Name
- Urology syringe FDA UDI
- Generic Name
- General-purpose syringe, reusable FDA UDI
- Model / Reference
- 199 090 100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059082032054 FDA UDI
- 510(k) Number
- K971881 FDA UDI
- FDA Product Code
- FJL FDA UDI
- GMDN Term
- General-purpose syringe, reusable 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General-purpose syringe, reusable
Urology syringe by SOPRO-COMEG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose syringe, reusable.
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- Safety 1st — DOREL JUVENILE GROUP, INC. · Class I
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- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Safety 1st — DOREL JUVENILE GROUP, INC. · Class I
- Safety 1st — DOREL JUVENILE GROUP, INC. · Class I
Cleared under the same submission
K971881 also covers:
- Bipolar HF cable — SOPRO-COMEG GmbH
- Bipolar HF cable — SOPRO-COMEG GmbH
- Bipolar HF cable — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
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
- SOPRO-COMEG GmbH
Sources (1)
- FDA UDI d0088483-26d8-4298-847f-1ccd4360a14c 33 fields · synced May 29, 2026