Identity
- Trade Name
- Tigon Medical FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- 3.0S Vampire Fang FDA UDI
- Model / Reference
- TM-VAPT002 FDA UDI
- Description
- 3.0S Vampire Fang FDA UDI
Identifiers
- Catalog Number
- TM-VAPT002 FDA UDI
- Primary DI / UDI-DI
- 00850029805915 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone marrow biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone marrow biopsy needle, single-use
Tigon Medical by Tigon Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Monoject — Cardinalhealth · Class II
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- Bone Marrow Biopsy Needle, RBN-116 — RANFAC CORP. · Class II
- Faset — Dio Medical Co., Ltd. · U
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 I | Pending data |
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Manufacturer
- Manufacturer
- Tigon Medical Llc
Sources (1)
- FDA UDI c010ff75-0242-4f1d-8959-5bcf758390fe 34 fields · synced May 31, 2026