FDA.reportPublic FDA data

KOMET GUIDE PIN/SCREW

Primary DI
14053613162132
Brand
KOMET GUIDE PIN/SCREW
Company
Gebr. Brasseler GmbH & Co. KG
Model
GS901.050.032.M4
Catalog number
GS901.050.032 STE
Published
2018-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
24053613162139PackageGS11In Commercial Distribution
14053613162132PrimaryGS10
E226045460M41SecondaryHIBCC0
84053613162131Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2405361316213924053613162139
1405361316213214053613162132
8405361316213184053613162131

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613001738KOMET Surgical BurNC0310.010..M0NC0310.010.2023-01-31
E226000085G11KOMET Dental Tungsten Carbide BursH1.314.006.G1H1.314.0062023-01-19
E226000087AL1KOMET Dental Tungsten Carbide BursH1.314.008.ALH1.314.0082023-01-19
E226000091G11KOMET Dental Tungsten Carbide BursH1.314.014.G1H1.314.0142023-01-24
E226000092A11KOMET Dental Tungsten Carbide BursH1.314.016.A1H1.314.0162023-01-24
E226000104AL1KOMET Surgical BurH1.316.010.ALH1.316.0102023-01-24
E226000104G11KOMET Surgical BurH1.316.010.G1H1.316.0102023-01-24
E226000106AL1KOMET Surgical BurH1.316.014.ALH1.316.0142023-01-27
E226000108G11KOMET Surgical BurH1.316.018.G1H1.316.0182023-01-31
E226000109G11KOMET Surgical BurH1.316.023.G1H1.316.0232023-01-31
E226000150AU1KOMET Dental Tungsten Carbide BursH2.313.008.AUH2.313.0082023-01-31
14053613286302Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.422S05.005.422S2026-10-05
14053613286326Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.423S05.005.423S2026-10-05
14053613286418Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.465S05.005.465S2026-10-05
14053613286432Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.441S05.005.441S2026-10-05
14053613286661Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.203S05.005.203S2026-10-05
14053613286708Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.303S05.005.303S2026-10-05
14053613286814Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.200S05.519.200S2026-10-05
14053613287026Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.002S05.005.002S2026-10-05
E226000077AU1KOMET Dental Tungsten Carbide BursH1.313.010.AUH1.313.0102023-01-19

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