FDA.reportPublic FDA data

n/a

Primary DI
04048844007966
Brand
n/a
Company
implantcast GmbH
Model
02820002
Device description
impactor for cup insert
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844007966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844007966040488440079664048844007966

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
324369826
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048844017293NA258628002026-05-06
04048844017316NA258628102026-05-06
04048844111250NA258640002026-05-06
04048844111267NA258640052026-05-06
04048844111274NA258640102026-05-06
04048844111281NA258640152026-05-06
04048844150228n/a028200402026-05-06
04048844708344EPORE® XO022080422026-05-06
04048844708375EPORE® XO022080442026-05-06
04048844708405EPORE® XO022080462026-05-06
04048844708429EPORE® XO022080482026-05-06
04048844708450EPORE® XO022080522026-05-06
04048844708467EPORE® XO022080542026-05-06
04048844711566EPORE® XO022080562026-05-06
04048844711573EPORE® XO022080582026-05-06
04048844711580EPORE® XO022080602026-05-06
04048844711603EPORE® XO022080642026-05-06
04048844711610EPORE® XO022080662026-05-06
04048844711627EPORE® XO022080682026-05-06
04048844711634EPORE® XO022080702026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348215137861Longboard Revision Stem Monobloc Ø10 LO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137878Longboard Revision Stem Monobloc Ø11 LO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137885Longboard Revision Stem Monobloc Ø12 LO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137892Longboard Revision Stem Monobloc Ø12 SO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137908Longboard Revision Stem Monobloc Ø12 LO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137915Longboard Revision Stem Monobloc Ø12 SO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137922Longboard Revision Stem Monobloc Ø13 LO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137939Longboard Revision Stem Monobloc Ø13 SO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137946Longboard Revision Stem Monobloc Ø13 LO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137953Longboard Revision Stem Monobloc Ø13 SO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137960Longboard Revision Stem Monobloc Ø14 LO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137977Longboard Revision Stem Monobloc Ø14 SO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137984Longboard Revision Stem Monobloc Ø14 HO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215137991Longboard Revision Stem Monobloc Ø14 LO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138004Longboard Revision Stem Monobloc Ø14 SO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138011Longboard Revision Stem Monobloc Ø14 HO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138028Longboard Revision Stem Monobloc Ø15 LO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138035Longboard Revision Stem Monobloc Ø15 SO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138042Longboard Revision Stem Monobloc Ø15 HO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138059Longboard Revision Stem Monobloc Ø15 LO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138066Longboard Revision Stem Monobloc Ø15 SO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138073Longboard Revision Stem Monobloc Ø15 HO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138080Longboard Revision Stem Monobloc Ø16 LO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138097Longboard Revision Stem Monobloc Ø16 SO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138103Longboard Revision Stem Monobloc Ø16 HO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138110Longboard Revision Stem Monobloc Ø16 LO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138127Longboard Revision Stem Monobloc Ø16 SO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138134Longboard Revision Stem Monobloc Ø16 HO 245mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138141Longboard Revision Stem Monobloc Ø17 LO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10
09348215138158Longboard Revision Stem Monobloc Ø17 SO 190mmSIGNATURE ORTHOPAEDICS PTY LTDOQI2025-10-10