FDA.reportPublic FDA data

KOMET GUIDE PIN/SCREW

Primary DI
14053613298657
Brand
KOMET GUIDE PIN/SCREW
Company
Gebr. Brasseler GmbH & Co. KG
Model
GP004.076.030.M4
Catalog number
GP004.076.030
Published
2026-10-14
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

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131264000KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWSGebr. Brasseler GmbH & Co. KG2013-07-26HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24053613298654PackageGS11In Commercial Distribution
14053613298657PrimaryGS10
84053613298656Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2405361329865424053613298654
1405361329865714053613298657
8405361329865684053613298656

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Regulatory Flags#

DUNS number
317409001
Device count
4
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
14053613286586Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.106S05.005.106S2026-10-07
14053613286593Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.102S05.005.102S2026-10-07
14053613286616Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.104S05.005.104S2026-10-07
14053613286647Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.405S05.005.405S2026-10-07
14053613286678Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.204S05.005.204S2026-10-07
14053613286746Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.007S05.005.007S2026-10-07
14053613286760Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.004S05.005.004S2026-10-07
14053613286951Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.305S05.519.305S2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057717550535BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550542BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550566BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550580BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550597BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550610BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550627BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550641BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550665BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550689BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550702BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550726BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550009BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550016BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550023BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550030BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550047BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550061BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550290BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550313BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550368BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550382BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550405BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550429BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550443BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550467BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550481BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550504BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550528BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550559BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09