Equinoxe

Primary DI
10885862611086
Brand
Equinoxe
Company
Exactech, Inc.
Model
315-58-15
Catalog number
315-58-15
Published
2022-05-10
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
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862611086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586261108610885862611086

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

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
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
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
00889024706828Mini Baseplate Sizer Cannulated HandleBiomet Orthopedics, LLCKWS2026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleBiomet Orthopedics, LLCKWS2026-03-19
10885862648549EquinoxeExactech, Inc.KWS2026-03-19
10885862648556EquinoxeExactech, Inc.KWS2026-03-19
10885862648563EquinoxeExactech, Inc.KWS2026-03-19
10885862656582EquinoxeExactech, Inc.KWS2026-02-09
00840338607669Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607713Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607720Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612342Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612366Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612373Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612380Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00889024692794Augmented BP Reamer Guide ExtractorBiomet Orthopedics, LLCKWS2025-12-18
00889024703742Versa-DialĀ® Shoulder SystemBiomet Orthopedics, LLCKWS2025-12-09
00885556919354AETOS Shoulder SystemSmith & Nephew, Inc.KWS2025-11-17
00889024691476Identity HumeralZimmer, Inc.KWS2025-09-22
00889024691445Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691490Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691599Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691605Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691612Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691629Identity HumeralZimmer, Inc.KWS2025-09-17
10885862657527EquinoxeExactech, Inc.KWS2025-09-09
10885862657534EquinoxeExactech, Inc.KWS2025-09-09
10885862657541EquinoxeExactech, Inc.KWS2025-09-09
10885862657558EquinoxeExactech, Inc.KWS2025-09-09
10885862657572EquinoxeExactech, Inc.KWS2025-09-09
10885862657602EquinoxeExactech, Inc.KWS2025-09-09
10885862657626EquinoxeExactech, Inc.KWS2025-09-09