Batrik K-Wire & Steinman Pins SU78.2030

GUDID 00690521012967

4" Double Trocar, 0.062" diameter-pkg-6

Batrik Medical Manufacturing Inc

Orthopaedic bone wire

• Primary Device ID: 00690521012967
• NIH Device Record Key: cc7aa0e7-0d43-4cce-a44b-0ca3535cbea5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Batrik K-Wire & Steinman Pins
• Version Model Number: SU78.2030
• Catalog Number: SU78.2030
• Company DUNS: 243880700
• Company Name: Batrik Medical Manufacturing Inc
• Device Count: 1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690521012967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100736

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

[00690521012967]

Moist Heat or Steam Sterilization

[00690521012967]

Moist Heat or Steam Sterilization

[00690521012967]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-20

On-Brand Devices [Batrik K-Wire & Steinman Pins]

• 00690521013803: 9" Single Trocar, 0.118" diameter-pkg-6
• 00690521013797: 9" Double Trocar, 0.078" diameter-pkg-6
• 00690521013377: 12" Single Trocar, 1.1" diameter-pkg-6
• 00690521013353: 9" Single Trocar, 0.062" diameter-pkg-6
• 00690521013209: 4" Single Trocar, 0.062" diameter-pkg-6
• 00690521013193: 4" Single Trocar, 0.054" diameter-pkg-
• 00690521013186: 4" Single Trocar, 0.047" diameter-pkg 6
• 00690521013117: 9" Double Trocar, 0.062" diameter-pkg-6
• 00690521013100: 9" Double Trocar, 0.054" diameter-pkg-6
• 00690521013094: 9" Double Trocar, 0.047" diameter-pkg-6
• 00690521013087: 9" Double Trocar, 0.039" diameter-pkg-6
• 00690521013063: 6" Double Trocar, 0.062" diameter-pkg-6
• 00690521013049: 6" Double Trocar, 0.047" diameter-pkg-6
• 00690521012967: 4" Double Trocar, 0.062" diameter-pkg-6
• 00690521012929: 5" Double Trocar, 0.062" diameter-pkg-6
• 00690521013162: 4" Single Trocar, 0.031" diameter-pkg 6