FDA.reportPublic FDA data

INHANCE

Primary DI
10603295538240
Brand
INHANCE
Company
DEPUY (IRELAND)
Model
5200-00-040
Catalog number
520000040
Device description
INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40mm CEMENTLESS
Published
2021-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10603295538240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329553824010603295538240

GMDN Terms#

Term, Definition table
TermDefinition
Humeral metaphyseal anchorA sterile implantable device designed to provide fixation within the humeral metaphysis for the attachment of a dedicated humeral head prosthesis. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is in the form of a small framework to achieve a mechanical interlock with bone without the use of bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295085980GLOBAL UNITE2100-70-2502100702502018-06-15
10603295088196GLOBAL ADVANTAGE2128-02-0502128020502018-09-24
10603295130192ATTUNE2544-01-0032544010032018-09-24
10603295130208ATTUNE2544-01-0042544010042018-09-24
10603295130222ATTUNE2544-01-0062544010062018-09-24
10603295395423ATTUNE2544-01-0092544010092018-09-24
10603295431275DEPUY REACH9505-05-1349505051342018-09-24
10603295431596DEPUY REACH9505-05-1359505051352018-09-24
10603295440222ATTUNE2546-00-4242546004242016-12-05
10603295443780ATTUNE2544-91-0012544910012020-06-11
10603295443797ATTUNE2544-91-0022544910022020-06-11
10603295443803ATTUNE2544-91-0032544910032020-06-11
10603295443810ATTUNE2544-91-0042544910042020-06-11
10603295451297ATTUNE2546-00-4162546004162016-12-05
10603295493549ATTUNE2544-11-0032544110032017-04-10
10603295496229ATTUNE2546-00-5162546005162018-01-24
10603295543879RECLAIM74-1000-1157410001152026-01-23
10603295543916RECLAIM74-1000-1207410001202026-01-23
10603295503309ATTUNE1506-61-3101506613102026-01-13
10603295503316ATTUNE1506-61-3201506613202026-01-13

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