FDA.reportPublic FDA data

CUP PUSHER HEAD

Primary DI
00889024585201
Brand
CUP PUSHER HEAD
Company
Zimmer, Inc.
Model
SSI005704
Catalog number
SSI005704
Published
2020-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024585201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024585201008890245852018890245852010889024585201

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument adaptor, reusableA connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. This is a reusable device.

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) 343-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868150876Affixus®8151113008151113002026-03-20
00887868150333Affixus®8151103008151103002026-03-19
00887868150340Affixus®8151103208151103202026-03-19
00887868150357Affixus®8151103408151103402026-03-19
00887868150364Affixus®8151103608151103602026-03-19
00887868150371Affixus®8151103808151103802026-03-19
00887868150388Affixus®8151104008151104002026-03-19
00887868150395Affixus®8151104208151104202026-03-19
00887868150401Affixus®8151114208151114202026-03-19
00887868150555Affixus®8151123008151123002026-03-19
00887868150562Affixus®8151123208151123202026-03-19
00887868150579Affixus®8151123408151123402026-03-19
00887868150586Affixus®8151123608151123602026-03-19
00887868150593Affixus®8151123808151123802026-03-19
00887868150609Affixus®8151124008151124002026-03-19
00887868150616Affixus®8151124208151124202026-03-19
00887868150883Affixus®8151113208151113202026-03-19
00887868150890Affixus®8151113408151113402026-03-19
00887868150906Affixus®8151113608151113602026-03-19
00887868150913Affixus®8151113808151113802026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862648150EquinoxeExactech, Inc.HWA2026-03-19
09421038412220Enztec XR Trinket M8X1.0-01ENZTEC LIMITEDHWA2026-03-13
00840277133403Innomed, Inc.INNOMED, INC.HWA2026-03-11
00810123209934Adler Instrument CompanyAdler, Inc.HWA2026-03-03
05056405508578Charnley Femoral Prosthesis PusherPLATTS & NISBETT LIMITEDHWA2026-02-11
00822409133178N/AOrtho Development CorporationHWA2026-02-05
00822409133185N/AOrtho Development CorporationHWA2026-02-05
00822409133192N/AOrtho Development CorporationHWA2026-02-05
00822409133215N/AOrtho Development CorporationHWA2026-02-05
10603295554974EMPHASYSDEPUY ORTHOPAEDICS, INC.HWA2026-02-04
04026575048168General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
04026575080182General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2026-02-02
08800017299358BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887734BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887826BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373887833BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888021BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
08806373888045BENCOX Surgical InstrumentsCorentec Co., LtdHWA2026-01-12
09421028112536Enztec Classic OCI - Trinket 5/16-24 UNF-02ENZTEC LIMITEDHWA2026-01-12
09421028113540Enztec Classic OCI - Trinket 3/8-16 UNC-01ENZTEC LIMITEDHWA2026-01-12
09421028113557Enztec Classic OCI - Trinket 5/16-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
09421028113571Enztec Classic OCI - Trinket 3/8-24 UNF-01ENZTEC LIMITEDHWA2026-01-12
04026575448500General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448517General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
04026575448524General InstrumentWALDEMAR LINK GmbH & Co. KGHWA2025-11-07
09421038410516 ATTUNE FEMORAL IMPACTORENZTEC LIMITEDHWA2025-10-21
09421038410523ATTUNE FEMORAL IMPACTOR HEADENZTEC LIMITEDHWA2025-10-21
00190446924470DJO SURGICALEncore Medical, L.P.HWA2025-10-10
09309000394289MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30
09309000394296MAC SurgicalMAC SURGICAL PTY LTDHWA2025-09-30