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Trek

FDA UDI

Class II (US FDA UDI)

by Bard Peripheral Vascular

Identity

Trade Name
Trek FDA UDI
Generic Name
Vertebral bone biopsy procedure kit, single-use FDA UDI
Device Name
Trek™ Bone Lesion Biopsy Kit, 11g x 6cm Introducer, 13g x 10.8cm Biopsy FDA UDI
Model / Reference
TKL1106 FDA UDI
Description
Trek™ Bone Lesion Biopsy Kit, 11g x 6cm Introducer, 13g x 10.8cm Biopsy FDA UDI

Identifiers

Catalog Number
TKL1106 FDA UDI
Primary DI / UDI-DI
00801741201448 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Vertebral bone biopsy procedure kit, single-use 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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 13 Gauge FDA UDI
Length — 10.8 Centimeter FDA UDI

Category: Vertebral bone biopsy procedure kit, single-use

Trek by Bard Peripheral Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral bone biopsy procedure kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bard Peripheral Vascular

Sources (1)

  • FDA UDI 61b3cb37-dd17-48b9-a2d8-a5b6c85d802d 36 fields · synced May 30, 2026