Blazer-C Curved Injection System-Mv

FDA UDI

Class I (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: BLAZER-C CURVED INJECTION SYSTEM-MV FDA UDI
Generic Name: Bone marrow biopsy procedure kit FDA UDI
Model / Reference: BZK3160 FDA UDI

Identifiers

Primary DI / UDI-DI: 00815212026973 FDA UDI
510(k) Number: K070293 FDA UDI
FDA Product Code: OCJ FDA UDI
GMDN Term: Bone marrow biopsy procedure 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Bone marrow biopsy procedure kit

Blazer-C Curved Injection System-Mv by Izi Medical Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Izi Medical Products Llc

Sources (1)

FDA UDI 90e10b3e-d318-4011-ba17-cecfe5932971 33 fields · synced May 30, 2026