KOMET GUIDE PIN/SCREW GS910.080.040 STE

GUDID 24053613281397

Gebr. Brasseler GmbH & Co. KG

Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative bone pin/screw, sterile Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 24053613281397
• NIH Device Record Key: 75dbdb92-ba19-414d-9fea-3445c4d3b0f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOMET GUIDE PIN/SCREW
• Version Model Number: GS910.080.040.M5
• Catalog Number: GS910.080.040 STE
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	14053613281390 [Primary]
GS1	24053613281397 [Package]; Contains: 14053613281390; Package: [1 Units]; In Commercial Distribution
GS1	84053613281399 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-15
• Device Publish Date: 2020-10-07

On-Brand Devices [KOMET GUIDE PIN/SCREW]

• 24053613279097: GS909.027.032.M5
• 24053613279080: GS908.056.032.M5
• 24053613279073: GS907.067.032.M5
• 24053613279066: GS907A.076.032.M5
• 24053613279059: GP005.076.032.M5
• 24053613278939: GP001A.089.032.M4
• 24053613278922: GP002A.089.032.M4
• 24053613219208: GP007.075.032
• 24053613219192: GP007.075.032
• 24053613215378: GS905.030.032
• 24053613214395: GS903A.062.032
• E226045460K41: GS901.050.032
• E226049152K41: GS901A.050.032
• 24053613176099: GS904.150.030
• 24053613176082: GS904.100.030
• 24053613172855: GS901.033.032
• 24053613167691: GS903.062.032
• 24053613164805: GS903.062.032
• 24053613164492: GS901.050.032
• E226045945K41: GS902.150.032
• 24053613164430: GP002.089.032
• 24053613163099: GS902.150.032
• 24053613162139: GS901.050.032
• 14053613162125: GP001.089.032
• 24053613282042: GP005.067.032.M4
• 24053613281397: GS910.080.040.M5
• 24053613282622: GP003A.27.30.M5
• 24053613282066: GP005.67.32.M5
• 24053613281663: GP001A.76.31.M4
• 24053613281465: GS910.170.40.M5
• 24053613281458: GS910.140.40.M5
• 24053613281441: GS910.140.32.M5
• 24053613281434: GS910.110.40.M5
• 24053613281403: GS910.110.32.M5
• 84053613265146: GP002A.89.32.K0
• 84053613209119: GP001A.89.32.K0
• 24053613206536: GS903A.62.32.M4
• 24053613206529: GS901A.50.32.M4
• 84053613204237: GS903.62.32.K0
• 14053613176108: GS904.100.40.M4
• 84053613175988: GS904.100.40.K4
• 84053613175971: GS904.150.30.K4
• 84053613175964: GS904.100.30.K4
• 84053613175360: GS905.30.32.K0
• 84053613175193: GS904.100.40.K0
• 84053613175186: GS904.150.30.K0
• 84053613175179: GS904.100.30.K0
• 84053613175155: GS901.33.32.K0
• 84053613174622: GS905.50.32.K0
• 24053613167318: GP003.70.23.M4