FDA.reportPublic FDA data

KOMET PIN DRIVER

Primary DI
14053613279649
Brand
KOMET PIN DRIVER
Company
Gebr. Brasseler GmbH & Co. KG
Model
GS900.055.020.K0
Catalog number
GS900.055.020
Published
2020-12-18
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
GFCDriver, Surgical, Pin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFCDriver, Surgical, PinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053613279642Direct MarkingGS10
14053613279649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053613279642040536132796424053613279642
1405361327964914053613279649

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool adaptorA connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317409001
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613295632Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.905S05.005.905S2026-10-20
14053613295656Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.907S05.005.907S2026-10-20
14053613286692Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.301S05.005.301S2026-10-19
14053613286975Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.072S05.005.072S2026-10-19
14053613286999Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.074S05.005.074S2026-10-19
14053613287002Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.075S05.005.075S2026-10-19
14053613287019Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.302S05.005.302S2026-10-19
14053613286562Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.501S05.005.501S2026-10-14
14053613286654Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.202S05.005.202S2026-10-14
14053613286906Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.190S05.519.190S2026-10-14
14053613298657KOMET GUIDE PIN/SCREWGP004.076.030.M4GP004.076.0302026-10-14
14053613286609Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.103S05.005.103S2026-10-13
14053613298275Reciprocating Saw Blade for ConMed®/Linvatec® Hall®AR-400-203AR-400-2032026-10-13
14053613298282Reciprocating Saw Blade for ConMed®/Linvatec® Hall®AR-400-204AR-400-2042026-10-13
14053613286579Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.101S05.005.101S2026-10-09
14053613286685Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.205S05.005.205S2026-10-09
14053613286739Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.001S05.005.001S2026-10-09
14053613286753Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.003S05.005.003S2026-10-09
14053613298336Pin DriverIN-20500IN-205002026-10-09
14053613286371Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.432S05.005.432S2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613298336Pin DriverGebr. Brasseler GmbH & Co. KGGFC2026-10-09
00840286860390Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2026-07-09
08806162109436AnyPlus®GS Medical Co., Ltd.GFC2026-01-28
03662663108645Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCGFC2025-11-12
00842188130304K-WiresTrimed, INC.GFC2025-07-08
00841132197066PediNailORTHOPEDIATRICS CORP.GFC2025-06-05
00840194472401PNP FemurORTHOPEDIATRICS CORP.GFC2025-05-28
00840286842129Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286842136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286846714Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855044Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855051Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855068Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855143Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855150Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855167Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286859950Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286843867UniSyn Hip SystemShalby Advanced Technologies, Inc.GFC2025-05-20
14053613292136PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292143PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292150PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613293164PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
04053613293167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
00840286846707Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-14
08800104058714CASSIOPEIA Cervical Plate SystemGS Medical Co., Ltd.GFC2025-03-17
04042409452987NAaap Implantate AGGFC2025-02-26
04042409453007NAaap Implantate AGGFC2025-02-26
04042409453021NAaap Implantate AGGFC2025-02-26