Identity
- Trade Name
- UltiCare FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Model / Reference
- 99999 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00357515999993 FDA UDI
- FDA Product Code
- FMI FDA UDIFMF FDA UDIMEG FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI880.5860 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
Category: Hypodermic needle, single-use
UltiCare by Ulti Med, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080600 also covers:
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 |
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Manufacturer
- Manufacturer
- Ulti Med, Inc.
Sources (1)
- FDA UDI 2756c767-9271-4ec3-9785-a1cf0773b614 33 fields · synced May 31, 2026