FDA.reportPublic FDA data

NA

Primary DI
10885862086129
Brand
NA
Company
Exactech, Inc.
Model
315-98-48
Catalog number
315-98-48
Device description
INSTRUMENT POST AUG TRIAL -M, LEFT
Published
2022-09-20
Public version status
Update
Distribution status
Not 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
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862086129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586208612910885862086129

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder glenoid fossa prosthesis trialA copy of a final shoulder glenoid fossa prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is cup-like in shape and typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
true
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
10885862088130Equinoxe321-98-08321-98-082022-10-04
10885862086075NA315-98-43315-98-432022-09-20
10885862086082NA315-98-44315-98-442022-09-20
10885862086099NA315-98-45315-98-452022-09-20
10885862086105NA315-98-46315-98-462022-09-20
10885862086112NA315-98-47315-98-472022-09-20
10885862086136NA315-98-49315-98-492022-09-20
10885862086143NA315-98-50315-98-502022-09-20
10885862086150NA315-98-51315-98-512022-09-20
10885862086167NA315-98-52315-98-522022-09-20
10885862086174NA315-98-53315-98-532022-09-20
10885862086181NA315-98-54315-98-542022-09-20
10885862253620GPS521-78-03521-78-032022-09-19
10885862052162NA205-55-09205-55-092022-08-25
10885862052179NA205-55-11205-55-112022-08-25
10885862052186NA205-55-13205-55-132022-08-25
10885862052193NA205-55-15205-55-152022-08-25
10885862085733Equinoxe315-98-01315-98-012022-08-18
10885862085740Equinoxe315-98-02315-98-022022-08-18
10885862085757Equinoxe315-98-03315-98-032022-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606191715Overwatch PCFSPINAL ELEMENTS, INC.HWT2026-07-31
00840311211470Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWT2026-07-30
18257200103096ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103102ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103119ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103126ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103133ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103140ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103157ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103164ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103522ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103539ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103546ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103553ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103560ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103577ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103584ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103591ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103607ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103614ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103782ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103799ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103805ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103812ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103829ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103836ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103843ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103850ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103867ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103935ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17