FDA.reportPublic FDA data

M/DN®

Primary DI
00889024041172
Brand
M/DN®
Company
Zimmer, Inc.
Model
2241-01-01
Published
2016-07-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024041172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024041172008890240411728890240411720889024041172

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28
00889024081277XtraFix® Large External Fixation System00-5210-050-0300-5210-050-032016-09-28
00889024081284XtraFix® Large External Fixation System00-5210-050-0400-5210-050-042016-09-28
00889024081307XtraFix® Large External Fixation System00-5210-050-0600-5210-050-062016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862660527AcuMatchExactech, Inc.HWT2026-05-28
10885862660541AcuMatchExactech, Inc.HWT2026-05-28
10885862660558AcuMatchExactech, Inc.HWT2026-05-28
10885862660565AcuMatchExactech, Inc.HWT2026-05-28
07613327524536INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524543INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524550INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327548716InstrumentHowmedica Osteonics Corp.HWT2024-02-22
07613327565850INSTRUMENTHowmedica Osteonics Corp.HWT2024-01-08
07613327459005NAStryker Leibinger GmbH & Co. KGHWT2019-07-17
07640185341166ROMEO 2 PAD INSTRUMENTATIONSpineArt SAHWT2019-02-12
07640185341173ROMEO 2 PAD INSTRUMENTATIONSpineArt SAHWT2019-02-12
07640185341180ROMEO 2 PAD INSTRUMENTATIONSpineArt SAHWT2019-02-12
07640185341197ROMEO 2 PAD INSTRUMENTATIONSpineArt SAHWT2019-02-12
07640185341203ROMEO 2 PAD INSTRUMENTATIONSpineArt SAHWT2019-02-12
07640185341210ROMEO 2 PAD INSTRUMENTATIONSpineArt SAHWT2019-02-12
07640185341227ROMEO 2 PAD INSTRUMENTATIONSpineArt SAHWT2019-02-12
07640185341234ROMEO 2 PAD INSTRUMENTATIONSpineArt SAHWT2019-02-12
07640178983731JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983748JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983755JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983762JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983779JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983786JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983793JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983809JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983816JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983823JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983830JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01
07640178983847JULIET ® INSTRUMENTATIONSpineArt SAHWT2019-02-01