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Lee Medical

FDA UDI

Class II (US FDA UDI)

by Tarca LLC

Identity

Trade Name
Lee Medical FDA UDI
Generic Name
Bone biopsy needle FDA UDI
Device Name
Pediatric LEE ® Bone Marrow Biopsy Needle 13 Gauge – 2 1/2 inch (64mm) FDA UDI
Model / Reference
B-133 FDA UDI
Description
Pediatric LEE ® Bone Marrow Biopsy Needle 13 Gauge – 2 1/2 inch (64mm) FDA UDI

Identifiers

Catalog Number
B-133 FDA UDI
Primary DI / UDI-DI
00850048404045 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Bone biopsy needle 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

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

No

FDA UDI

Category: Bone biopsy needle

Lee Medical by Tarca LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone biopsy needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tarca LLC

Sources (1)

  • FDA UDI e454b9b1-e60b-4491-ae86-57203c39d0bd 34 fields · synced May 31, 2026