Identity
- Trade Name
- BMT-11B,F/G FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- BMT-11B,F/G PN74080-01M FDA UDI
- Model / Reference
- 11 GAUGE x 4" FDA UDI
- Description
- BMT-11B,F/G PN74080-01M FDA UDI
Identifiers
- Catalog Number
- BMT-11B FDA UDI
- Primary DI / UDI-DI
- M9797408001M0 FDA UDI
- 510(k) Number
- K983187 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone marrow biopsy procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
- Length — 4 Inch FDA UDINeedle Gauge — 11 Gauge FDA UDI
Category: Bone marrow biopsy procedure kit
Bmt-11b, F/G by Ranfac Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K983187 also covers:
- Monoject — Cardinalhealth
- Monoject — Cardinalhealth
- Monoject — Cardinalhealth
- Monoject — Cardinalhealth
- BMET-11, F/G — RANFAC CORP.
- BMET-11-2, 2% LIDOCAINE — RANFAC CORP.
- BMET-11A, F/G — RANFAC CORP.
- BMET-11AL — RANFAC CORP.
- BMET-11ANL, F/G — RANFAC CORP.
- BMET-11NL, F/G — RANFAC CORP.
- BMET-8A — RANFAC CORP.
- Bone Marrow Biopsy Needle, RBN-114 — RANFAC CORP.
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
- Ranfac Corp.
Sources (1)
- FDA UDI 94dec0fc-7ea7-4417-90ea-31971c095e7f 37 fields · synced May 30, 2026