FDA.reportPublic FDA data

EXp Acetabular Shell and Liner

Primary DI
10840843109181
Brand
EXp Acetabular Shell and Liner
Company
GLOBUS MEDICAL, INC.
Model
SC3345-32-5052
Device description
32 MM EXp Hooded Liner
Published
2015-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840843109181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084084310918110840843109181

GMDN Terms#

Term, Definition table
TermDefinition
Constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
139105691
Device count
1
DM exempt
false
Premarket exempt
true
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
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01
00889095782486CREO6200.14052019-08-01
00193982647650ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.31272026-02-10
00193982647667ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.37202026-02-10
00193982647674ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50212026-02-10
00193982647681ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50222026-02-10
00889095305401COALITION MIS6136.10032016-10-11
00193982534011ANTHEM1181.82022026-01-27
00193982534028ANTHEM1181.82032026-01-27
00193982534035ANTHEM1181.82042026-01-27
00193982534042ANTHEM1181.82052026-01-27
00193982534059ANTHEM1181.82062026-01-27
00193982534066ANTHEM1181.82072026-01-27
00193982534073ANTHEM1181.82082026-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024686595G7® Revision Acetabular SystemZimmer, Inc.OQG2026-02-10
00889024686601G7® Revision Acetabular SystemZimmer, Inc.OQG2026-02-10
00889024686618G7® Revision Acetabular SystemZimmer, Inc.OQG2026-02-10
00190446893349DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893363DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893370DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893387DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893400DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893424DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893431DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893448DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893486DJO SURGICALEncore Medical, L.P.OQG2025-12-04
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08033390277228ArTTLIMACORPORATE SPAOQG2025-09-25
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