FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403050589
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
GU8366
Catalog number
GU8366
Device description
"V. Mueller YOUNG ANTERIOR RETRACTOR ACUTE ANGLE BLDE 3X1-5/8"" (7.6X4.1CM) WIDE OVERALL LENGTH 7-5/8"" (19.5CM)"
Published
2018-08-30
Public version status
Update
Distribution status
Not 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
10885403050589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540305058910885403050589

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

Regulatory Flags#

DUNS number
832696038
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
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18
10885403228131Safe-TTPT1005SDFTPT1005SDF2018-07-18
10885403231780JamshidiBAK4511DFBAK4511DF2016-09-23
10885403231896Safe-T-CentesisPIG1260TCDFPIG1260TCDF2018-07-18
10885403231902NATPT1000CDFTPT1000CDF2018-07-18

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