FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403050909
Brand
V. Mueller
Company
STERIS CORPORATION
Model
GU8777
Catalog number
GU8777
Device description
V. Mueller GIL-VERNET RETRACTOR BLADE 13MM WIDE MALLEABLE SHAFT OVERALL LENGTH 11-3/8 inches 29CM
Published
2018-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGNRETRACTOR, NON-SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403050909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540305090910885403050909

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811019394INKAThe Trustee for KAISER FAMILY TRUSTFGN2025-11-19
09348811019400INKAThe Trustee for KAISER FAMILY TRUSTFGN2025-11-19
07898506814732QuinelatoSchobell Industrial LtdaFGN2023-01-09
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269397Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269427Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269489Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269564Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269663Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269670Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269694Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269724Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269748Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269762Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269779Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269816Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780270256Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268543Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268550Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23