FDA.reportPublic FDA data

Versa-Dial

Primary DI
00889024577008
Brand
Versa-Dial
Company
Biomet Orthopedics, LLC
Model
SSI002779
Catalog number
SSI002779
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
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024577008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024577008008890245770088890245770080889024577008

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
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
00889024706071Identity Inlay Small Tooth ReamerZimmer, Inc.MBF2026-02-23
00889024703759Versa-Dial® Shoulder SystemBiomet Orthopedics, LLCMBF2025-12-02
00889024691551Identity HumeralZimmer, Inc.MBF2025-09-22
00889024691582Identity HumeralZimmer, Inc.MBF2025-09-22
B1130S1GK000030Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
B1132L2HG700380Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
B1132L2HS700040Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
B1132L2HS700050Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
00889024691506Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691513Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691520Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691643Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691650Identity HumeralZimmer, Inc.MBF2025-09-17
B1132L2HC000040Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.MBF2025-09-13
B1132L1S0400000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S0600000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S0800000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S1000000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S1200000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S1400000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L2HI000040Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L2HI000110Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2025-05-12
B1132N1HS000400Shoulder Innovations TSAShoulder Innovations, Inc.MBF2025-04-18
B1132N1HS000460Shoulder Innovations TSAShoulder Innovations, Inc.MBF2025-04-18
B1132N1HS000520Shoulder Innovations TSAShoulder Innovations, Inc.MBF2025-04-18
B1132R2HC000050Shoulder Innovations IM Cut GuideShoulder Innovations, Inc.MBF2025-04-18
B1132R2HC000080Shoulder Innovations IM Cut GuideShoulder Innovations, Inc.MBF2025-04-18
B1132R2HC000090Shoulder Innovations IM Cut GuideShoulder Innovations, Inc.MBF2025-04-18
00887868580697Identity® Shoulder SystemZimmer, Inc.MBF2024-09-09
B1132L2HC000010Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2024-09-01