FDA.reportPublic FDA data

NA

Primary DI
00889024023246
Brand
NA
Company
Zimmer, Inc.
Model
471-04
Catalog number
00-0471-004-00
Published
2016-07-26
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
HWLSET, HOLLOW MILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWLSet, Hollow MillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024023246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024023246008890240232468890240232460889024023246

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
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
00889024710580Custom Femoral Lateralizing ReamerSSI008673SSI0086732026-07-20
00889024711495Z1 ExtractorSSI008663SSI0086632026-07-20
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10
00889024701458Identity® Shoulder System11007750110077502026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437019739966WasherCap™ Surgical Instrument SetABANZA TECNOMED SL.HWL2023-06-01
06973877662722RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662739RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662746RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662753RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662760RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662777RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662814RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662852RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662869RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877663019RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667932RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667956RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667963RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667970RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667987RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
04047844111673COSYSIGNUS Medizintechnik GmbHHWL2023-03-15
07613327417289INSTRUMENTHowmedica Osteonics Corp.HWL2018-06-01
00190776032548AvalignAvalign Technologies, Inc.HWL2017-05-01
00190776032555AvalignAvalign Technologies, Inc.HWL2017-05-01
00889024023215NAZimmer, Inc.HWL2016-07-26
00889024023222NAZimmer, Inc.HWL2016-07-26
00889024023239NAZimmer, Inc.HWL2016-07-26
00889024039742ZMS®Zimmer, Inc.HWL2016-07-26