FDA.reportPublic FDA data

PERFORM™ HUMERAL SYSTEM

Primary DI
00846832078547
Brand
PERFORM™ HUMERAL SYSTEM
Company
TORNIER, INC.
Model
DWT3363
Catalog number
DWT3363
Published
2020-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
00846832078547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832078547008468320785478468320785470846832078547

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 Diameter36Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
968990812
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846832077632PERFORM™ HUMERAL SYSTEMDWR13602020-11-10
00846832077649PERFORM™ HUMERAL SYSTEMDWR13632020-11-10
00846832077656PERFORM™ HUMERAL SYSTEMDWR13662020-11-10
00846832077663PERFORM™ HUMERAL SYSTEMDWR13902020-11-10
00846832077670PERFORM™ HUMERAL SYSTEMDWR13932020-11-10
00846832077687PERFORM™ HUMERAL SYSTEMDWR13962020-11-10
00846832077694PERFORM™ HUMERAL SYSTEMDWR23602020-11-10
00846832077700PERFORM™ HUMERAL SYSTEMDWR23632020-11-10
00846832077717PERFORM™ HUMERAL SYSTEMDWR23662020-11-10
00846832077724PERFORM™ HUMERAL SYSTEMDWR23902020-11-10
00846832077731PERFORM™ HUMERAL SYSTEMDWR23932020-11-10
00846832077748PERFORM™ HUMERAL SYSTEMDWR23962020-11-10
00846832077755PERFORM™ HUMERAL SYSTEMDWR24202020-11-10
00846832077762PERFORM™ HUMERAL SYSTEMDWR24232020-11-10
00846832077779PERFORM™ HUMERAL SYSTEMDWR24262020-11-10
00846832077786PERFORM™ HUMERAL SYSTEMDWR33302020-11-10
00846832077793PERFORM™ HUMERAL SYSTEMDWR33332020-11-10
00846832077809PERFORM™ HUMERAL SYSTEMDWR33362020-11-10
00846832077816PERFORM™ HUMERAL SYSTEMDWR33602020-11-10
00846832077823PERFORM™ HUMERAL SYSTEMDWR33632020-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868580710Identity® Shoulder SystemZimmer, Inc.PAO2024-09-09
00887868580758Identity® Shoulder SystemZimmer, Inc.PAO2024-09-09
04026575439751LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-07-12
04026575534746LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-07-11
04026575439546LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439553LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439560LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439577LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533510LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533527LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533534LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533541LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533558LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533565LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533572LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533589LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533596LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533602LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533619LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533626LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533633LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533640LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533411LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533428LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533442LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533657LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533718LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533725LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533732LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533749LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22