FDA.report

NA

Primary DI
00889024312258
Brand
NA
Company
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
Model
00-7053-062-20
Published
2016-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWMOSTEOTOME

Product Code Classifications

CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024312258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024312258008890243122588890243122580889024312258

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags

DUNS number
793120965
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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00889024317239Mergence™-S96-105-0000296-105-000022017-09-20
00889024317307Mergence™-S96-108-0300196-108-030012017-09-20
00889024317383Mergence™-S96-108-1011196-108-101112017-09-20
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00889024318076Mergence™-S96-108-5008196-108-500812017-09-20
00889024318137Mergence™-S96-108-5705196-108-570512017-09-20
00889024318304Mergence™-S96-108-6704196-108-670412017-09-20
00889024318427NA96-115-0021196-115-002112016-05-25
00889024318700NA96-115-1062196-115-106212016-05-25
00889024318830NA96-136-3209296-136-320922016-05-25
00889024319059NA96-151-3215296-151-321522016-05-25
00889024319080NA96-151-4008296-151-400822016-05-25
00889024320444Mergence™-S96-299-5500196-299-550012017-09-20
00889024465664NEXGEN® TRABECULAR METAL™00-5878-065-2900-5878-065-292016-08-08
00889024313088Trabecular Metal™06-101-0104106-101-010412015-09-24
00889024313095Trabecular Metal™06-101-0105106-101-010512015-09-17
00889024313101Trabecular Metal™06-101-0106106-101-010612015-09-17

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