FDA.reportPublic FDA data

GLOBAL UNITE

Primary DI
10603295004424
Brand
GLOBAL UNITE
Company
DEPUY (IRELAND)
Model
1100-40-010
Catalog number
110040010
Device description
GLOBAL UNITE ANATOMIC PROXIMAL BODY 128 DEGREE SIZE 12 POROCOAT
Published
2015-10-09
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
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133834000
K170748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133834000DEPUY GLOBAL UNITE SHOULDER SYSTEMDepuy(Ireland)2014-04-03KWS
K170748000GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018-01-11PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295004424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500442410603295004424

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder humeral body prosthesisA sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27
10603295541387ATTUNE1518-20-1141518201142021-08-27
10603295541394ATTUNE1518-20-1161518201162021-08-27
10603295541400ATTUNE1518-20-2051518202052021-08-27
10603295541417ATTUNE1518-20-2061518202062021-08-27
10603295541424ATTUNE1518-20-2071518202072021-08-27
10603295541431ATTUNE1518-20-2081518202082021-08-27
10603295541448ATTUNE1518-20-2101518202102021-08-27
10603295541455ATTUNE1518-20-2121518202122021-08-27
10603295541462ATTUNE1518-20-2141518202142021-08-27
10603295541479ATTUNE1518-20-2161518202162021-08-27
10603295541486ATTUNE1518-20-3051518203052021-08-27
10603295541493ATTUNE1518-20-3061518203062021-08-27
10603295541509ATTUNE1518-20-3071518203072021-08-27
10603295541516ATTUNE1518-20-3081518203082021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN170440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN180400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN180420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN180440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN180460Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180460Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN180480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23