FDA.reportPublic FDA data

Glenoid IRI Handle

Primary DI
00811813020006
Brand
Glenoid IRI Handle
Company
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
Model
M
Catalog number
0006-0001
Device description
The Glenoid IRI Handle Body is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly is indicated for use as part of the Glenoid Intelligent Reusable Instrument System (IRIS) in Total Shoulder Arthroplasty (TSA).
Published
2016-09-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811813020006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811813020006008118130200068118130200060811813020006

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, dark, cool place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2168005905info@customorthopaedics.com

Regulatory Flags#

DUNS number
078667390
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811813020525VisionAir 3D Stent0010-01262024-03-11
00811813020013Glenoid IRI BarrelM0006-00022016-09-02
00811813020020Glenoid IRIS Surgical TrayE0006-00112016-09-02
00811813020037Glenoid IRI CapJ0006-00032016-09-02
00811813020044Glenoid IRI Leg (10mm)L0006-0005-102016-09-02
00811813020051Glenoid IRI Leg (11mm)L0006-0005-112016-09-02
00811813020068Glenoid IRI Leg (12mm)L0006-0005-122016-09-02
00811813020075Glenoid IRI Leg (13mm)L0006-0005-132016-09-02
00811813020082Glenoid IRI Leg (14mm)L0006-0005-142016-09-02
00811813020099Glenoid IRI Leg (15mm)L0006-0005-152016-09-02
00811813020105Glenoid IRI Leg (16mm)L0006-0005-162016-09-02
00811813020112Glenoid IRI Leg (17mm)L0006-0005-172016-09-02
00811813020129Glenoid IRI Leg (18mm)L0006-0005-182016-09-02
00811813020136Glenoid IRI Leg (19mm)L0006-0005-192016-09-02
00811813020143Glenoid IRI Leg (20mm)L0006-0005-202016-09-02
00811813020150Glenoid IRI Leg (21mm)L0006-0005-212016-09-02
00811813020167Glenoid IRI Leg (22mm)L0006-0005-222016-09-02
00811813020174Glenoid IRI Leg (23mm)L0006-0005-232016-09-02
00811813020181Glenoid IRI Leg (24mm)L0006-0005-242016-09-02
00811813020198Glenoid IRI Leg (25 mm)L0006-0005-252016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097535678Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535692Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535715Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535739Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535753Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535777Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535791Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535814Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535838Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535852Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535876Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535890Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097534978Veritas rTSARestor3d, Inc.PHX2026-06-02
00840097534985Veritas rTSARestor3d, Inc.PHX2026-06-02
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWS2026-05-28
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07613327355093REUNIONStryker GmbHKWS2022-11-15
07613327355109REUNIONStryker GmbHKWS2022-11-15
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07613327355246REUNIONStryker GmbHKWS2022-11-15
07613327355260REUNIONStryker GmbHKWS2022-11-15
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07613327355345REUNIONStryker GmbHKWS2022-11-15
07613327355369REUNIONStryker GmbHKWS2022-11-15