FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862593009
Brand
Equinoxe
Company
Exactech, Inc.
Model
321-59-42
Catalog number
321-59-42
Device description
rTSA Reamer, 42mm
Published
2023-09-13
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

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
10885862593009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586259300910885862593009

GMDN Terms#

Term, Definition table
TermDefinition
Glenoid orthopaedic reamerAn orthopaedic surgical instrument designed to cut and resurface with precision the glenoid fossa for the acceptance of the glenoid fossa component of a shoulder joint prosthesis. The device is designed with a hemispherical head with an abrasive/cutting outer surface attached to a shaft for connection to a manual or powered handle. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
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
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26
10885862653772Alteon190-00-09190-00-092026-05-26
10885862653789Alteon190-00-10190-00-102026-05-26
10885862653796Alteon190-00-11190-00-112026-05-26
10885862653802Alteon190-00-12190-00-122026-05-26
10885862653819Alteon190-00-13190-00-132026-05-26
10885862653826Alteon190-00-14190-00-142026-05-26
10885862653833Alteon190-00-15190-00-152026-05-26
10885862653840Alteon190-01-02190-01-022026-05-26
10885862653857Alteon190-01-03190-01-032026-05-26
10885862653864Alteon190-01-04190-01-042026-05-26
10885862653871Alteon190-01-05190-01-052026-05-26
10885862653888Alteon190-01-06190-01-062026-05-26

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
03661489523618JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723421JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723438JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723445JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723452JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723469JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723476JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723483JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723490JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723506JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723537JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16