FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403087530
Brand
V. Mueller
Company
STERIS CORPORATION
Model
OA4080-003
Catalog number
OA4080003
Device description
Affinity BONE HOOKS SHARP HOOK DIAMETER 1-3/16 inches 3CM OVERALL LENGTH 9 inches 22.9CM
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
KIKHOOK, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIKHook, BoneGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403087530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540308753010885403087530

GMDN Terms#

Term, Definition table
TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. 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

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Primary DI, Brand, Company table
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00885556912003EVOSSmith & Nephew, Inc.KIK2025-11-12
00885556912010EVOSSmith & Nephew, Inc.KIK2025-11-12
00847538007930Bone Hook - SmallSYMMETRY MEDICAL INC.KIK2025-10-20
G767CBW1010Alira Medical DevicesAlira Medical Devices, LLCKIK2025-09-26
G767JSH1040Alira Medical DevicesAlira Medical Devices, LLCKIK2025-09-26
G767S1040110Alira Medical DevicesAlira Medical Devices, LLCKIK2025-09-26
00194613104870MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-08-01
00194613115746MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-08-01
00190776404697MillenniumAvalign Technologies, Inc.KIK2025-07-10
00190776401832MillenniumAvalign Technologies, Inc.KIK2025-06-13
00190776401849MillenniumAvalign Technologies, Inc.KIK2025-06-13
00190776401856MillenniumAvalign Technologies, Inc.KIK2025-06-13
00190776394912MillenniumAvalign Technologies, Inc.KIK2025-05-08
00190776394707MillenniumAvalign Technologies, Inc.KIK2025-05-07
08403207009739Anmuth Medical InternationalAnmuth Medical International, LLCKIK2025-03-24
00194613086817MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-03-21
00194613103774MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-03-21
00194613111267MSI Precision Specialty InstrumentsMed Saver, Inc.KIK2025-03-21
G586N882131B0Novo SurgicalNOVO SURGICAL, INC.KIK2024-10-25
00887868582318Affixus®Zimmer, Inc.KIK2024-10-17
00889795137111Phantom® Fibula Nail SystemParagon 28, Inc.KIK2024-09-24
00889795137234Phantom® Fibula Nail SystemParagon 28, Inc.KIK2024-09-24
00889795141248Phantom® Fibula Nail SystemParagon 28, Inc.KIK2024-09-24
00190776385514MillenniumAvalign Technologies, Inc.KIK2024-08-29
00190776384760MillenniumAvalign Technologies, Inc.KIK2024-08-22
00887482064054Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KIK2024-08-07
00887482064061Symmetry BoneASPEN SURGICAL PRODUCTS, INC.KIK2024-08-07
B8039059150ORTHOMEDORTHO-MED, INC.KIK2024-07-03