Identity
- Trade Name
- HYPO NDL 33GX1/2" HARD PACK FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- HYPO NDL 33GX1/2" HARD PACK, 100/BX, 1000/CS TSK3313 FDA UDI
- Model / Reference
- 26393 FDA UDI
- Description
- HYPO NDL 33GX1/2" HARD PACK, 100/BX, 1000/CS TSK3313 FDA UDI
Identifiers
- Catalog Number
- 26393 FDA UDI
- Primary DI / UDI-DI
- 00020221263930 FDA UDI
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Hypodermic needle, single-use 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
Category: Hypodermic needle, single-use
Hypo Ndl 33gx1/2" Hard Pack by Exel International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hypodermic needle, single-use.
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Cleared under the same submission
K861153 also covers:
- 50-60mL SYR ONLY L-L BULK NON STERILE — Exel International
- EXEL 0.3mL INS SYR 28GX1/2" — Exel International
- EXEL 0.3mL INS SYR 30GX1/2" — Exel International
- EXEL 10-12mL SYR L-L BULK NON STRILE; — Exel International
- EXEL 1mL ALLERGY SYR 27GX1/2", REGULAR BEVEL — Exel International
- EXEL 1mL SYR ONLY LUER LOCK BULK NON-STERILE — Exel International
- EXEL 1mL SYR ONLY LUER LOCK BULK NON-STERILE **CUSTOM** — Exel International
- EXEL 1ml SYR ONLY LUER LOCK BULK, STERILE — Exel International
- EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL — Exel International
- EXEL 20-25mL SYR ONLY L-L BULK NON STERILE; — Exel International
- EXEL 20-25mL SYR ONLY L-S/N-S — Exel International
- EXEL 30-35mL SYR ONLY L-S /N-S — Exel International
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
- Exel International
Sources (1)
- FDA UDI f62fdbc1-8ff1-4209-a2aa-d77c5310aeb6 36 fields · synced May 30, 2026