FDA.reportPublic FDA data

KOMET GUIDE PIN/SCREW

Primary DI
24053613176082
Brand
KOMET GUIDE PIN/SCREW
Company
Gebr. Brasseler GmbH & Co. KG
Model
GS904.100.030
Catalog number
GS904.100.030 STE
Published
2018-07-12
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
JDWPin, Fixation, Threaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

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
24053613176082PackageGS11In Commercial Distribution
14053613176085PrimaryGS10
E226048013M41SecondaryHIBCC0
84053613176084Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2405361317608224053613176082
1405361317608514053613176085
8405361317608484053613176084

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative bone pin/screw, sterileA small sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317409001
Device count
2
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
14053613286364Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.431S05.005.431S2026-10-01
14053613286395Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.433S05.005.433S2026-10-01
14053613286425Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.442S05.005.442S2026-10-01
14053613286449Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.451S05.005.451S2026-10-01
14053613286456Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.452S05.005.452S2026-10-01
14053613286470Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.453S05.005.453S2026-10-01
14053613286487Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.454S05.005.454S2026-10-01
14053613286494Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.445S05.005.445S2026-10-01
14053613286722Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.305S05.005.305S2026-10-01
14053613286777Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.005S05.005.005S2026-10-01
14053613286784Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.106S05.519.106S2026-10-01
14053613286791Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.113S05.519.113S2026-10-01
14053613286944Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.304S05.519.304S2026-10-01
14053613001493KOMET Surgical BurNC0303.004..M0NC0303.004.2023-01-31
E226000081AU1KOMET Dental Tungsten Carbide BursH1.313.018.AUH1.313.0182023-01-19
14053613298343KOMET Surgical BurS27261.501..M0S27261.501.2026-09-30
14053613298350KOMET Surgical BurS27262.501..M0S27262.501.2026-09-30
E226000077AU1KOMET Dental Tungsten Carbide BursH1.313.010.AUH1.313.0102023-01-19
E226100004991KOMET Dental Diamond InstrumentsS5878.314.016.A2S5878.314.0162023-02-01
14053613286630Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.201S05.005.201S2026-09-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08059386747407DOLPHIXCITIEFFE SRLJDW2025-04-02
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