FDA.report

PE insert 0° 4mm offset

Primary DI
04048844328252
Brand
PE insert 0° 4mm offset
Company
implantcast GmbH
Model
02813648
Published
2021-02-08
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

Related Records

Product Codes

CodeName
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048844328252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048844328252040488443282524048844328252

GMDN Terms

TermDefinition
Non-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 does not include a stabilizing component to limit the range of motion of the hip.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
324369826
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

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04048844358716MUTARS®770301052026-03-24
04048844358792MUTARS®770301252026-03-24
04048844358839MUTARS®770301352026-03-24
04048844732103n/a800930002026-03-24
04048844738150implaFit®800820252026-03-24
04048844731977implaFit®800920002026-03-20
04048844731984implaFit®800920012026-03-20
04048844731991implaFit®800920022026-03-20
04048844732004implaFit®800920032026-03-20
04048844732028implaFit®800920062026-03-20
04048844732042implaFit®800920072026-03-20
04048844732059implaFit®800920082026-03-20
04048844732066implaFit®800920092026-03-20
04048844732080implaFit®800920112026-03-20
04048844732097implaFit®800920122026-03-20
04048844781101implaFit®800920052026-03-20
04048844693350implaFit®800900002026-03-17
04048844693374implaFit®800900022026-03-17
04048844693381implaFit®800900032026-03-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10885862660596N/AExactech, Inc.OQI2026-03-19
10885862660640N/AExactech, Inc.OQI2026-03-19
10885862660671NovationExactech, Inc.OQI2026-03-19
00889024686519G7® Revision Acetabular SystemZimmer, Inc.OQI2026-02-10
00889024686533G7® Revision Acetabular SystemZimmer, Inc.OQI2026-02-10
00889024686540G7® Revision Acetabular SystemZimmer, Inc.OQI2026-02-10
00889024686755G7® Revision Acetabular SystemZimmer, Inc.OQI2026-02-10
04719872143024U-Motion IIUNITED ORTHOPEDIC CORP.OQI2025-09-15
04719886893663U-Motion IIUNITED ORTHOPEDIC CORP.OQI2025-09-05
09348215134518Nebula Standard Offset Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134525Nebula Standard Offset Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134532Nebula Standard Offset Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134549Nebula Standard Offset Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134556Nebula Standard Offset Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134563Nebula Standard Offset Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134570Nebula Standard Offset Size 6SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134587Nebula Standard Offset Size 7SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134594Nebula Standard Offset Size 8SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134600Nebula Standard Offset Size 9SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215134617Nebula Standard Offset Size 10SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137502Origin TT Standard Offset Size 6SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137519Origin TT Standard Offset Size 7SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137526Origin TT Standard Offset Size 8SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137533Origin TT Standard Offset Size 9SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137540Origin TT Standard Offset Size 10SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137557Origin TT Standard Offset Size 11SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137564Origin TT Standard Offset Size 12SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137571Origin TT High Offset Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137588Origin TT High Offset Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20
09348215137595Origin TT High Offset Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQI2025-03-20