FDA.reportPublic FDA data

Versa-Dial

Primary DI
00889024577152
Brand
Versa-Dial
Company
Biomet Orthopedics, LLC
Model
SSI002795
Catalog number
SSI002795
Published
2019-06-21
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
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024577152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024577152008890245771528890245771520889024577152

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.

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
129278169
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862648099EquinoxeExactech, Inc.HSD2026-03-19
10885862648105EquinoxeExactech, Inc.HSD2026-03-19
10885862648129EquinoxeExactech, Inc.HSD2026-03-19
10885862648136EquinoxeExactech, Inc.HSD2026-03-19
10885862648167EquinoxeExactech, Inc.HSD2026-03-19
10885862648174EquinoxeExactech, Inc.HSD2026-03-19
10885862648259EquinoxeExactech, Inc.HSD2026-03-19
10885862648266EquinoxeExactech, Inc.HSD2026-03-19
10885862648273EquinoxeExactech, Inc.HSD2026-03-19
10885862648280EquinoxeExactech, Inc.HSD2026-03-19
10885862648297EquinoxeExactech, Inc.HSD2026-03-19
10885862648303EquinoxeExactech, Inc.HSD2026-03-19
10885862662446EquinoxeExactech, Inc.HSD2026-03-19
10885862662453EquinoxeExactech, Inc.HSD2026-03-19
10885862662460EquinoxeExactech, Inc.HSD2026-03-19
10885862662477EquinoxeExactech, Inc.HSD2026-03-19
10885862662484EquinoxeExactech, Inc.HSD2026-03-19
10885862662491EquinoxeExactech, Inc.HSD2026-03-19
10885862665782EquinoxeExactech, Inc.HSD2026-03-19
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