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DropSafe® Insulin Safety Syringe with Fixed Needle
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- DropSafe® Insulin Safety Syringe with Fixed Needle FDA UDI
- Generic Name
- Insulin syringe/needle, safety FDA UDI
- Device Name
- DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safety shield to cover the needle. This device is intended for the delivery of U-100 insulin. FDA UDI
- Model / Reference
- 0.5ml 31G x 6mm FDA UDI
- Description
- DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safety shield to cover the needle. This device is intended for the delivery of U-100 insulin. FDA UDI
Identifiers
- Catalog Number
- 6081 FDA UDI
- Primary DI / UDI-DI
- 85903999600774 FDA UDI
- 510(k) Number
- K132681 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Insulin syringe/needle, safety 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
Yes
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
No
FDA UDI
Category: Insulin syringe/needle, safety
DropSafe® Insulin Safety Syringe with Fixed Needle by Htl Strefa S A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, safety.
- SecureSafe Syringe With Safety Needle — Dynarex Corp. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, — MediVena, LLC · Class II
- Endure — ENDURE INDUSTRIES, INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · 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 0.5mL 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Htl Strefa S A
Sources (1)
- FDA UDI f27e048f-9d44-4261-85f3-92ae99e3c5b5 36 fields · synced Jun 8, 2026