FDA.reportPublic FDA data

UltraClip® II Breast Tissue Marker

Primary DI
00801741032271
Brand
UltraClip® II Breast Tissue Marker
Company
Bard Peripheral Vascular, Inc.
Model
861217
Catalog number
861217
Device description
ULTRACLIP® II breast tissue marker 17g x 12cm needle, titanium ribbon clip
Published
2015-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZPCLIP, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2
GDWStaple, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741032278PackageGS15In Commercial Distribution
00801741032271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103227810801741032278
00801741032271008017410322718017410322710801741032271

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Needle Gauge17Gauge

Contacts#

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

Regulatory Flags#

DUNS number
135057938
Device count
1
Lot or batch
true
Expiration date on label
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
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
08904255200005MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200012MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200029MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909590MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909606MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909613MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909620MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909637MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909644MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909941MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909958MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909965MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909972MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909989MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255203877MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203938MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203945MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203952MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225503MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225510MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225527MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225534MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225541MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225558MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18