FDA.reportPublic FDA data

GUIDE PIN/SCREW

Primary DI
14053613282601
Brand
GUIDE PIN/SCREW
Company
Gebr. Brasseler GmbH & Co. KG
Model
OC002A.089.032 STE
Catalog number
OC002A.089.032 STE
Published
2020-10-05
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
24053613282608PackageGS11In Commercial Distribution
14053613282601PrimaryGS10
84053613282600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2405361328260824053613282608
1405361328260114053613282601
8405361328260084053613282600

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative orthopaedic bone pin/screw, single-useA small rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) and/or implantable device (e.g., fixation plate) to the 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/devices. 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
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
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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Primary DI, Brand, Company table
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