Identity
- Trade Name
- Sure Fine™ Insulin Syringes 0.3cc 31G 8mm (HUM) FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- Sure Fine™ Insulin Syringes 0.3cc 31G 8mm (HUM) FDA UDI
- Model / Reference
- SFI33181 FDA UDI
- Description
- Sure Fine™ Insulin Syringes 0.3cc 31G 8mm (HUM) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800052608047 FDA UDI
- 510(k) Number
- K210848 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
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
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Insulin syringe/needle, basic
Sure Fine™ Insulin Syringes 0.3cc 31G 8mm (HUM) by Shina Med Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, basic.
- EasyTouch — MHC Medical Products · Class II
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- droplet insulin syringes — HTL STREFA S A · Class II
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- LiteTouch — AMITY HOLDINGS, LLC · Class II
- Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II
Cleared under the same submission
K210848 also covers:
- Sure Fine™ Insulin Syringes 0.3cc 29G 12.7mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.3cc 30G 12.7mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.3cc 30G 8mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.3cc 31G 6mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.3cc 31G 8mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.5cc 28G 12.7mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.5cc 29G 12.7mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.5cc 30G 12.7mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.5cc 30G 8mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.5cc 31G 6mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 0.5cc 31G 8mm — SHINA MED CORPORATION
- Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm — SHINA MED CORPORATION
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
- Shina Med Corporation
Sources (1)
- FDA UDI a5754a62-eabb-4997-8b3d-f996ab4b5bde 34 fields · synced May 30, 2026