FDA.reportPublic FDA data

NA

Primary DI
04055207021033
Brand
NA
Company
Richard Wolf GmbH
Model
8840762
Catalog number
8840.762
Device description
TEM CLIP APPLICATOR Ø 6MM WL 435MM TL 555mm, take-apart, reusable
Published
2022-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDOApplier, surgical, clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207021033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207021033040552070210334055207021033

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip applierA device intended to be used in combination with a compatible flexible endoscope for the application of a gastrointestinal endoscopic clip(s) [not included] to the mucosal lining of the gastrointestinal (GI) tract for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects during an endoscopic procedure. It typically consists of an insertion sheath, a mechanism at the distal end for applying the clips, and a control handle at the proximal end for firing the clips into the target tissue. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length435Millimeter
Outer Diameter6Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29
04055207038529RIWO880288.022026-05-29
04055207038536RIWO880488.042026-05-29
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902118InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
08800042706111Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042706128Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042706135Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042706142Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042700065Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700904Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700911Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700928Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701369Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701376Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701390Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701406Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702878Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702885Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702892Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702908Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702915Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702922Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08809756910081Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
08809756910104Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
10381780540595CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
10381780540601CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
08809756910074Artisential Clip Applier LargeLIVSMEDGDO2025-09-08