FDA.reportPublic FDA data

MultiCup™

Primary DI
04048266008763
Brand
MultiCup™
Company
Merete GmbH
Model
HF40028
Device description
MultiCup Inlay Impactor Plate 28 mm Standard non-sterile
Published
2021-11-01
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWAIMPACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048266008763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048266008763040482660087634048266008763

GMDN Terms#

Term, Definition table
TermDefinition
Diaphysis prosthesisAn artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(630)869-1092service@merete-medical.com

Regulatory Flags#

DUNS number
313267265
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048266076762N/AFH20014FH200142021-11-01
04048266079077OsteoBridge™N/AGA314132021-11-01
04048266079107OsteoBridge™N/AGA316132021-11-01
04048266079114OsteoBridge™N/AGA316152021-11-01
04048266079138OsteoBridge™N/AGA414132021-11-01
04048266079145OsteoBridge™N/AGA414152021-11-01
04048266079152OsteoBridge™N/AGA414202021-11-01
04048266079169OsteoBridge™N/AGA416132021-11-01
04048266079183OsteoBridge™N/AGA416202021-11-01
04048266079190OsteoBridge™N/AGA418132021-11-01
04048266131003OsteoBridge™N/AGA314202021-11-01
04048266138200OsteoBridge™N/AGA414252021-11-01
04048266144294OsteoBridge™N/AGA318152021-11-01
04048266130853OsteoBridge™ IKA Knee Arthrodesis Nailwithout Collar curved 20 300GA220302015-10-15
04048266078780OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 10 130GA110132015-10-15
04048266078797OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 10 150GA110152015-10-15
04048266078827OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 12 150GA112152015-10-15
04048266078841OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 14 130GA114132015-10-15
04048266078858OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 14 150GA114152015-10-15
04048266078872OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 16 130GA116132015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00822409135721N/AOrtho Development CorporationHWA2026-07-16
07630055307781Positioning handle - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307798Positioning handle - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
07630055307804Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307811Offset Cup Impactor - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
00840286860406Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWA2026-07-09
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
08809885739751PYXIS 3D Titanium Cervical Cage, CloseGS Medical Co., Ltd.HWA2026-01-28
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
00841732162709GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162716GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
07630055302458Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2020-04-23
07630055302465Offset Cup Impactor - M10x1.5 interfaceIncipio Devices SAHWA2020-04-23
07640178983052JULIET ® INSTRUMENTATIONSpineArt SAHWA2019-02-01
10705034717364NASynthes GmbHHWA2019-01-18
10603295423324ATTUNEDEPUY (IRELAND)HWA2018-09-24
M684201620111MICROPORTMicroport Orthopedics Inc.HWA2018-09-13
10705034720883NASYNTHES (U.S.A.) LPHWA2018-08-17
10381780408451Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780479406Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780266389Integra™Allograft Wedge SystemAscension Orthopedics, Inc.HWA2018-04-13
10381780282457Integra® PyroCarbonAscension Orthopedics, Inc.HWA2018-04-13
10381780279495K2™ Hemi Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780279907KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780224815Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224822Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23