FDA.reportPublic FDA data

Guide Pin Smooth

Primary DI
84053613294535
Brand
Guide Pin Smooth
Company
Gebr. Brasseler GmbH & Co. KG
Model
800-05-215
Catalog number
800-05-215
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
04053613294539Direct MarkingGS10
14053613294536PrimaryGS10
84053613294535Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053613294539040536132945394053613294539
1405361329453614053613294536
8405361329453584053613294535

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317409001
Device count
20
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613286357Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.425S05.005.425S2026-09-25
14053613286388Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.464S05.005.464S2026-09-25
14053613286401Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.434S05.005.434S2026-09-25
14053613286463Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.466S05.005.466S2026-09-25
14053613286500Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.435S05.005.435S2026-09-25
14053613286623Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.105S05.005.105S2026-09-25
14053613286807Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.170S05.519.170S2026-09-25
14053613286838Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.230S05.519.230S2026-09-25
14053613286845Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.104S05.519.104S2026-09-25
14053613286852Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.103S05.519.103S2026-09-25
14053613286869Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.250S05.519.250S2026-09-25
14053613286876Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.105S05.519.105S2026-09-25
14053613286883Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.150S05.519.150S2026-09-25
14053613286890Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.100S05.519.100S2026-09-25
14053613286913Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.301S05.519.301S2026-09-25
14053613286920Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.302S05.519.302S2026-09-25
14053613286937Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.303S05.519.303S2026-09-25
14053613293133KOMET Surgical BurSC2834.502..K1SC2834.502.2026-09-25
14053613295649Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.906S05.005.906S2026-09-25
14053613295694Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.914S05.005.914S2026-09-25

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