Identity
- Trade Name
- Syringes (w/o needle) FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe FDA UDI
- Model / Reference
- 6992 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784699226 FDA UDI
- 510(k) Number
- K060211 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Metered-delivery hypodermic syringe
Syringes (w/o needle) by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metered-delivery hypodermic syringe.
- TERUMO — Terumo (Philippines) Corporation · Class II
- SURGUARD2 — Terumo (Philippines) Corporation · Class II
- ZevRx STERILE INSULIN SYRINGE 5/16” | 1/2CC | 30G — HOME AIDE DIAGNOSTICS, INC. · Class II
- Syringe with needle — ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD · Class II
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- Monoject — Cardinalhealth · Class II
- Jelco — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K060211 also covers:
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
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
- Dynarex Corp.
Sources (1)
- FDA UDI 7c7e43f3-b108-4a01-b510-90215e6cae60 33 fields · synced May 30, 2026