FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403010026
Brand
V. Mueller
Company
STERIS CORPORATION
Model
AU12503
Catalog number
AU12503
Device description
WIET-DERLACKI MODIFIED MOBILIZER, ANGLE, CONE-SHAPED SERRATED 1MM TIP OVERALL LENGTH 6-1/2 inches16.5CM
Published
2018-07-13
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
KAJMOBILIZER, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAJMobilizer, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403010026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540301002610885403010026

GMDN Terms#

Term, Definition table
TermDefinition
ENT mobilizerA hand-held, manual, stainless steel surgical instrument with a small diameter shaft tapering from the handle typically intended to be used to remobilize the footplate of the stapes to relieve conductive hearing impairment due to otosclerosis or middle ear disease. The distal tip of the shaft is bent at a slight angle to the shaft and expands to form a small platform that is larger than the distal shaft. The distal surface of the platform is shaped into a set of small ridges or projections which can be of several geometric shapes. 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
DM exempt
true
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
00757770406791Bausch + LombBausch & Lomb IncorporatedKAJ2026-02-11
00757770406838Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00757770436231Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00840183527495BR Surgical, LLCBR Surgical, LLCKAJ2024-11-26
00887482042472Symmetry HoughASPEN SURGICAL PRODUCTS, INC.KAJ2024-08-20
00190776044602AvalignAvalign Technologies, Inc.KAJ2023-09-28
00190776320263MillenniumAvalign Technologies, Inc.KAJ2023-06-23
14026704805522PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
54026704805520PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
00842331165078Novo Surgical Inc. NOVO SURGICAL, INC.KAJ2022-11-13
00190660109691Ambler SurgicalAMBLER SURGICAL CORP.KAJ2021-01-04
10381780082439Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAJ2018-10-24
10885403009778V. MuellerSTERIS CORPORATIONKAJ2018-07-13