FDA.reportPublic FDA data

DuraClip(TM) Repositionable Hemostasis Clip

Primary DI
16932619740033
Brand
DuraClip(TM) Repositionable Hemostasis Clip
Company
Transmed (China) Co., Ltd.
Model
DC0235W
Catalog number
DC0235W
Device description
Open width16±2mm the max OD of insertion part2.6mm working length2350mm coated
Published
2018-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26932619740030PackageGS110In Commercial Distribution
36932619740037PackageGS110In Commercial Distribution
16932619740033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693261974003026932619740030
3693261974003736932619740037
1693261974003316932619740033

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, short-termA sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length235Centimeter
Outer Diameter2.6Millimeter

Regulatory Flags#

DUNS number
545996571
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16932619740019DuraClip(TM) Repositionable Hemostasis ClipDC0235DC02352016-07-11
16932619740026DuraClip(TM) Repositionable Hemostasis ClipDC0165DC01652016-07-11
36932619740037DuraClipDC0235WDC0235W2018-12-14
36932619740013DuraClipDC0235DC02352016-07-11
36932619740020DuraClipDC0165DC01652016-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760441721113Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441721212Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441722110Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441722219Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441723117Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
03760441723216Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
06959664900086NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900178NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900185NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
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