Identity
- Trade Name
- Blazer FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- Blazer-C Vertebral Augmentation Kit FDA UDI
- Model / Reference
- BZK3130 FDA UDI
- Description
- Blazer-C Vertebral Augmentation Kit FDA UDI
Identifiers
- Catalog Number
- BZK3130 FDA UDI
- Primary DI / UDI-DI
- 00813478020193 FDA UDI
- 510(k) Number
- K070293 FDA UDI
- FDA Product Code
- OCJ FDA UDI
- GMDN Term
- Bone access channel kit 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
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
Category: Bone access channel kit
Blazer by Benvenue Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone access channel kit.
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- Drill — Shanghai Kinetic Medical Co., Ltd. · Class II
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Cleared under the same submission
K070293 also covers:
- Blazer — BENVENUE MEDICAL, INC.
- Kiva — BENVENUE MEDICAL, INC.
- Kiva — BENVENUE MEDICAL, INC.
- BLAZER INTRODUCER, BEVEL TIP — IZI MEDICAL PRODUCTS LLC
- BLAZER-C CURVED INJECTION SYSTEM-MV — IZI MEDICAL PRODUCTS LLC
- BLAZER:C VAS — IZI MEDICAL PRODUCTS LLC
- Blazer Bone Drill — IZI MEDICAL PRODUCTS LLC
- Blazer Introducer - diamond tip — IZI MEDICAL PRODUCTS LLC
- Blazer-C Curved Injection System — IZI MEDICAL PRODUCTS LLC
- KIVA Gen 2 Bone Drill — IZI MEDICAL PRODUCTS LLC
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
- Benvenue Medical, Inc.
Sources (1)
- FDA UDI 4410b6dc-1c4d-4ae9-b44c-ff2a2eef10f5 36 fields · synced Jun 8, 2026