FDA.reportPublic FDA data

Trek

Primary DI
00801741201455
Brand
Trek
Company
Bard Peripheral Vascular, Inc.
Model
TKL1110
Catalog number
TKL1110
Device description
Trek™ Bone Lesion Biopsy Kit, 11g x 10cm Introducer, 13g x 14.8cm Biopsy
Published
2022-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741201452PackageGS15In Commercial Distribution
00801741201455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174120145210801741201452
00801741201455008017412014558017412014550801741201455

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral bone biopsy procedure kit, single-useA collection of sterile devices, equipment, and supplies used to obtain a bone specimen from the vertebrae of a patient (the bony segments of the spinal column) for histological analysis. It typically contains a metal cannula which can have various tip designs (e.g., bevelled, pyramidal, scoop-, or diamond-shaped) and stylet(s), a biopsy needle, an obturator, a needle holder, syringes, and connecting tube. The specimen can be used for the detection of cancer, infection, or other bone disorders. The device may also be used for vertebral infusion (e.g., injection of bone cement). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14.8Centimeter
Needle Gauge13Gauge

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741234184EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234156EnCor EnCompass™ENCPSCENCPSC2026-02-04
00801741234163EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
00801741234095EnCor EnCompass™ENCP7GENCP7G2026-01-30
00801741234132EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
00801741234118EnCor EnCompass™ENCP12GENCP12G2026-01-28
00801741234149EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
00801741234170EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937278630643CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630650CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630667CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630674CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630681CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630698CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630704CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630827CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630834CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630841CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630858CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630865CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630872CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630889CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630896CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630902CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630919CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630926CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631046CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631053CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631060CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631077CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631084CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631091CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631107CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631114CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631121CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631138CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631145CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631268CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08