← Back to catalogue

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 15cm Introducer, 13g x 19.8cm Biopsy FDA UDI
Model / Reference
TKL1115 FDA UDI
Description
Trek™ Bone Lesion Biopsy Kit, 11g x 15cm Introducer, 13g x 19.8cm Biopsy FDA UDI

Identifiers

Catalog Number
TKL1115 FDA UDI
Primary DI / UDI-DI
00801741201462 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
Length — 19.8 Centimeter FDA UDI
Needle Gauge — 13 Gauge 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bard Peripheral Vascular

Sources (1)

  • FDA UDI 4d6a742b-b562-481a-bb93-fad7a2a2284e 36 fields · synced Jun 8, 2026