FDA.reportPublic FDA data

NA

Primary DI
04055207015414
Brand
NA
Company
Richard Wolf GmbH
Model
8389911
Catalog number
8389.911
Device description
CLIP APPLICATOR Ø 10MM WL 340MM reusable
Published
2016-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC
GDOApplier, surgical, clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207015414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207015414040552070154144055207015414

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
Length340Millimeter
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method
Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide
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
04055207071786NA830211N8302.112026-10-01
04055207071830NA8302101N8302.1012026-10-01
04055207000649NA799000179900012021-04-05
04055207000656NA799000279900022021-04-05
04055207058862NA799000379900032021-04-05
04055207070055NA10300103.002024-06-03
04055207058886NA82295822952022-08-09
04055207038758FUSION DESIGN8095098095092022-03-08
04055207055199FUSION DESIGN8070028070022022-03-08
04055207065730VERTEBRIS1520826415208.2642022-11-01
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G141521149260Carnegie Surgical LLCCarnegie Surgical LLCFHQ2026-09-30
00724995279622V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286248V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286286V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320164V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320263V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320317V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320324V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320331V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320348V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00840319759424Hayden MedicalHayden Medical, Inc.FHQ2026-09-04
00190776419684MillenniumAvalign Technologies, Inc.FHQ2026-08-25
14026704928702WECKTELEFLEX INCORPORATEDGDO2026-08-25
14026704928436WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928443WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928450WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928467WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928474WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928481WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928498WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928504WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928511WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928528WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928535WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928542WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928559WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928566WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928573WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928580WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928597WECKTELEFLEX INCORPORATEDGDO2026-08-21