FDA.reportPublic FDA data

PERFORM™ HUMERAL SYSTEM

Primary DI
00846832078318
Brand
PERFORM™ HUMERAL SYSTEM
Company
TORNIER, INC.
Model
DWS4426
Catalog number
DWS4426
Published
2020-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832078318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832078318008468320783188468320783180846832078318

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene reverse shoulder prosthesis cupA sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter42Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840338607515Made-To-Order902706990270692026-04-28
00840338604033Tornier HRSARS10252ARS102522025-11-18
00840338604040Tornier HRSARS10253ARS102532025-11-18
00846832068678AEQUALIS™ FLEX REVIVE™ARS742301ARS7423012019-03-04
00846832068685AEQUALIS™ FLEX REVIVE™ARS742302ARS7423022019-03-04
00846832068692AEQUALIS™ FLEX REVIVE™ARS742303ARS7423032019-03-05
00846832068708AEQUALIS™ FLEX REVIVE™ARS742304ARS7423042019-03-04
00846832068715AEQUALIS™ FLEX REVIVE™ARS742305ARS7423052019-03-04
00846832068722AEQUALIS™ FLEX REVIVE™ARS742306ARS7423062019-03-04
00846832068739AEQUALIS™ FLEX REVIVE™ARS742401ARS7424012019-03-04
00846832068746AEQUALIS™ FLEX REVIVE™ARS742402ARS7424022019-03-04
00846832068777AEQUALIS™ FLEX REVIVE™ARS742405ARS7424052019-03-04
00846832068784AEQUALIS™ FLEX REVIVE™ARS742406ARS7424062019-03-04
00846832068814AEQUALIS™ FLEX REVIVE™ARS742501ARS7425012019-03-04
00846832068821AEQUALIS™ FLEX REVIVE™ARS742502ARS7425022019-03-04
00846832068838AEQUALIS™ FLEX REVIVE™ARS742503ARS7425032019-03-04
00846832068845AEQUALIS™ FLEX REVIVE™ARS742504ARS7425042019-03-04
00846832068852AEQUALIS™ FLEX REVIVE™ARS742505ARS7425052019-03-04
00846832068869AEQUALIS™ FLEX REVIVE™ARS742506ARS7425062019-03-04
00846832006588Futura™ FGTFGT-202015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862657244EquinoxeExactech, Inc.PAO2026-07-07
10885862657251EquinoxeExactech, Inc.PAO2026-07-07
10885862657268EquinoxeExactech, Inc.PAO2026-07-07
10885862657275EquinoxeExactech, Inc.PAO2026-07-07
10885862657282EquinoxeExactech, Inc.PAO2026-07-07
10885862657299EquinoxeExactech, Inc.PAO2026-07-07
10885862657305EquinoxeExactech, Inc.PAO2026-07-07
10885862657312EquinoxeExactech, Inc.PAO2026-07-07
10885862657329EquinoxeExactech, Inc.PAO2026-07-07
10885862657336EquinoxeExactech, Inc.PAO2026-07-07
10885862657343EquinoxeExactech, Inc.PAO2026-07-07
10885862657350EquinoxeExactech, Inc.PAO2026-07-07
10885862657367EquinoxeExactech, Inc.PAO2026-07-07
10885862657374EquinoxeExactech, Inc.PAO2026-07-07
10885862657381EquinoxeExactech, Inc.PAO2026-07-07
10885862657398EquinoxeExactech, Inc.PAO2026-07-07
10885862657442EquinoxeExactech, Inc.PAO2026-07-07
10885862657459EquinoxeExactech, Inc.PAO2026-07-07
10885862657466EquinoxeExactech, Inc.PAO2026-07-07
10885862657473EquinoxeExactech, Inc.PAO2026-07-07
08033390266567PRIMALIMACORPORATE SPAPAO2024-07-27
08033390266574PRIMALIMACORPORATE SPAPAO2024-07-27
08033390267472PRIMALIMACORPORATE SPAPAO2024-07-27
08033390267496PRIMALIMACORPORATE SPAPAO2024-07-27
08033390267502PRIMALIMACORPORATE SPAPAO2024-07-27
08033390268486PRIMALIMACORPORATE SPAPAO2024-07-27
08033390268493PRIMALIMACORPORATE SPAPAO2024-07-27
08033390260312PRIMA TT GlenoidLIMACORPORATE SPAPAO2024-03-12
08033390260367PRIMA TT GlenoidLIMACORPORATE SPAPAO2024-03-12
08033390266536PRIMALIMACORPORATE SPAPAO2024-03-12