Identity
- Trade Name
- droplet insulin syringe FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- droplet insulin syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. FDA UDI
- Model / Reference
- 0.3ml, 30G x 12.5mm FDA UDI
- Description
- droplet insulin syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. FDA UDI
Identifiers
- Catalog Number
- 6028 FDA UDI
- Primary DI / UDI-DI
- 05907996097852 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Insulin syringe/needle, basic 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
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
Category: Insulin syringe/needle, basic
droplet insulin syringe by Htl Strefa S A — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Htl Strefa S A
Sources (2)
- FDA UDI b739c182-d603-4eaf-a892-b24470d35109 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 28, 2026