Identity
- Trade Name
- Sure Comfort FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- 0.3mL 29G 12.7mm Single use disposable insulin syringe with needle. Includes 100 sterile syringes in convenient 10 pack bags. FDA UDI
- Model / Reference
- 22-9003 FDA UDI
- Description
- 0.3mL 29G 12.7mm Single use disposable insulin syringe with needle. Includes 100 sterile syringes in convenient 10 pack bags. FDA UDI
Identifiers
- Catalog Number
- 22-9003 FDA UDI
- Primary DI / UDI-DI
- 00786227900353 FDA UDI
- 510(k) Number
- K152879 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
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
- Total Volume — 0.3 Milliliter FDA UDILength — 12.7 Millimeter FDA UDINeedle Gauge — 29 Gauge FDA UDI
Category: Insulin syringe/needle, basic
Sure Comfort by Allison Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Insulin syringe/needle, basic.
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Cleared under the same submission
K152879 also covers:
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, INC.
- Sure Comfort — ALLISON MEDICAL, 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
- Allison Medical, Inc.
Sources (1)
- FDA UDI aa9c5d2e-851f-46b6-91d4-cdee85feffba 37 fields · synced Jun 8, 2026