Identity
- Trade Name
- BTT FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- bone-marrow trasplantation needle 13G 11 cm FDA UDI
- Model / Reference
- BTT FDA UDI
- Description
- bone-marrow trasplantation needle 13G 11 cm FDA UDI
Identifiers
- Catalog Number
- BTT1311 FDA UDI
- Primary DI / UDI-DI
- 08033959222607 FDA UDI
- 510(k) Number
- K051506 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW 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
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: Bone marrow biopsy procedure kit
Btt by Sterylab Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K051506 also covers:
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
- ATA-CUT — STERYLAB SRL
- ATA-CUT — STERYLAB SRL
- ATA-CUT — STERYLAB SRL
- BEN — STERYLAB SRL
- BEN — STERYLAB SRL
- BEST-LISAS — STERYLAB SRL
- COMPLETE-CHIBA — STERYLAB SRL
- COMPLETE-CHIBA — STERYLAB SRL
- COMPLETE-CHIBA — STERYLAB SRL
- COMPLETE-CHIBA — STERYLAB SRL
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterylab Srl
Sources (1)
- FDA UDI 26f4b346-e319-4f11-907d-dfe1a0ead004 35 fields · synced Jun 8, 2026