Identity
- Trade Name
- Assure® ID INSULIN SAFETY SYRINGE 0.5mL 31G x 6mm FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe/needle FDA UDI
- Device Name
- Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. FDA UDI
- Model / Reference
- 253315 FDA UDI
- Description
- Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00015482253158 FDA UDI
- 510(k) Number
- K132681 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe/needle 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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 31 Gauge FDA UDILength — 6 Millimeter FDA UDITotal Volume — 0.5 Milliliter FDA UDI
Category: Metered-delivery hypodermic syringe/needle
Assure® ID INSULIN SAFETY SYRINGE 0.5mL 31G x 6mm by Arkray Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metered-delivery hypodermic syringe/needle.
- BD Integra — BECTON DICKINSON AND COMPANY · Class II
- Magellan — Cardinal Health 200, LLC · Class II
- Magellan — Cardinal Health 200, LLC · Class II
- VanishPoint® — Retractable Technologies, Inc. · Class II
- Suresafe 1ml Syringe — DMC MEDICAL LIMITED · Class II
- BD Integra — BECTON DICKINSON AND COMPANY · Class II
- VanishPoint® — Retractable Technologies, Inc. · Class II
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag · Class II
Cleared under the same submission
K132681 also covers:
- ASSURE® ID INSULIN SAFETY SYRINGE .3mL 29G x 1/2" — ARKRAY USA, INC.
- ASSURE® ID INSULIN SAFETY SYRINGE .3mL 31G x 5/16" — ARKRAY USA, INC.
- ASSURE® ID INSULIN SAFETY SYRINGE .5mL 31G x 5/16" — ARKRAY USA, INC.
- ASSURE® ID INSULIN SAFETY SYRINGE 1mL 31G x 5/16" — ARKRAY USA, INC.
- ASSURE® ID Safety Syringe .5mL 29G x 1/2" — ARKRAY USA, INC.
- ASSURE® ID Safety Syringe 1mL 29G x 1/2" — ARKRAY USA, INC.
- ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 1" — ARKRAY USA, INC.
- ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 5/8" — ARKRAY USA, INC.
- ASSURE® ID TB SAFETY SYRINGE 1mL 27G x 1/2" — ARKRAY USA, INC.
- ASSURE® ID TB SAFETY SYRINGE 1mL 28G x 1/2" — ARKRAY USA, INC.
- ASSURE® ID TB SAFETY SYRINGE 1mL 31G x 5/16" — ARKRAY USA, INC.
- Assure® ID INSULIN SAFETY SYRINGE 1mL 31G x 6mm — ARKRAY USA, INC.
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
- Arkray Usa, Inc.
Sources (1)
- FDA UDI 5cf1fc6d-e661-4442-bb27-5581f3de7f22 37 fields · synced May 29, 2026