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Exel 1ml Tuberculin Zero Dead Space Syringe With Permanently Attached Needle
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Exel 1ml Tuberculin Zero Dead Space Syringe With Permanently Attached Needle FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- EXEL 1CC TB 25GX5/8"-0-DEAD-SP FDA UDI
- Model / Reference
- 26046 FDA UDI
- Description
- EXEL 1CC TB 25GX5/8"-0-DEAD-SP FDA UDI
Identifiers
- Catalog Number
- 26046 FDA UDI
- Primary DI / UDI-DI
- 20020221260469 FDA UDI
- 510(k) Number
- K861153 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
- Not 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
Yes
FDA UDI
Exel 1ml Tuberculin Zero Dead Space Syringe With Permanently Attached Needle by Exel International — Class II — FDA UDI — listed in FDA GUDID
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 b0b62b9e-ce4a-443f-990e-c4b54803a9dd 36 fields · synced Jun 8, 2026