FDA.reportPublic FDA data

MP Monoblock - Instruments

Primary DI
04026575259441
Brand
MP Monoblock - Instruments
Company
WALDEMAR LINK GmbH & Co. KG
Model
136-202/03
Device description
Orthopaedic prosthesis instrument, reusable - General Instrument
Published
2022-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWRDRIVER, PROSTHESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575259441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575259441040265752594414026575259441

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315675488
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026575448678MobileLink Acetabular Cup System183-353/40183-353/402026-07-09
04026575448685MobileLink Acetabular Cup System183-363/40183-363/402026-07-09
04026575448760MobileLink Acetabular Cup System183-354/40183-354/402026-07-09
04026575448777MobileLink Acetabular Cup System183-355/40183-355/402026-07-09
04026575448784MobileLink Acetabular Cup System183-356/40183-356/402026-07-09
04026575448791MobileLink Acetabular Cup System183-364/40183-364/402026-07-09
04026575448807MobileLink Acetabular Cup System183-365/40183-365/402026-07-09
04026575448814MobileLink Acetabular Cup System183-366/40183-366/402026-07-09
04026575448821MobileLink Acetabular Cup System183-373/40183-373/402026-07-09
04026575448838MobileLink Acetabular Cup System183-374/40183-374/402026-07-09
04026575448845MobileLink Acetabular Cup System183-375/40183-375/402026-07-09
04026575448852MobileLink Acetabular Cup System183-376/40183-376/402026-07-09
04026575448869MobileLink Acetabular Cup System183-743/40183-743/402026-07-09
04026575448876MobileLink Acetabular Cup System183-744/40183-744/402026-07-09
04026575448883MobileLink Acetabular Cup System183-745/40183-745/402026-07-09
04026575448890MobileLink Acetabular Cup System183-746/40183-746/402026-07-09
04026575348213SPII Model Lubinus128-950/35128-950/352015-11-01
04026575348220SPII Model Lubinus128-951/35128-951/352015-11-01
04026575348237SPII Model Lubinus128-952/35128-952/352015-11-01
04026575348244SPII Model Lubinus128-953/35128-953/352015-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809926260299InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260312InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260329InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260336InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260343InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260350InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260367InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260374InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260381InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260398InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260404InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
G079C5070000120Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2026-04-22
07640332478462SCARLET® AC-TiSpineArt SAHWR2025-11-10
10603295559436INHANCE INTACTDEPUY (IRELAND)HWR2025-06-13
10603295551768INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-03-07
10603295551805INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
10603295560050INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
G079C5080000040MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
G079C5080000160MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
00887868561368VersaNail®Biomet Orthopedics, LLCHWR2023-09-07
09348215083069Dual Mobility Sleeve DriverSIGNATURE ORTHOPAEDICS PTY LTDHWR2023-01-27
G079C5070000030Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2022-09-23
10603295547631INHANCEDEPUY (IRELAND)HWR2022-05-16
10603295538912INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295538943INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539339INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539353INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539391INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295539476INHANCEDEPUY (IRELAND)HWR2021-08-30
00190446356820DJO SURGICALEncore Medical, L.P.HWR2021-02-12