BRISTOW LATARJET 285137

GUDID 10886705020713

Bristow - Latarjet Instability Shoulder Screw 46mm Titanium Screw & Top Hat; Quanitity: (1) Screw; (1) Top Hat

DEPUY MITEK, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705020713
• NIH Device Record Key: 16217576-be4e-491f-b6f5-8c562e8d505e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRISTOW LATARJET
• Version Model Number: 285137
• Catalog Number: 285137
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705020713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110763

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[10886705020713]

Moist Heat or Steam Sterilization

[10886705020713]

Moist Heat or Steam Sterilization

[10886705020713]

Moist Heat or Steam Sterilization

[10886705020713]

Moist Heat or Steam Sterilization

[10886705020713]

Moist Heat or Steam Sterilization

[10886705020713]

Moist Heat or Steam Sterilization

[10886705020713]

Moist Heat or Steam Sterilization

[10886705020713]

Moist Heat or Steam Sterilization

[10886705020713]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-08-30
• Device Publish Date: 2015-09-01

On-Brand Devices [BRISTOW LATARJET]

• 10886705017997: Bristow - Latarjet Instability Shoulder System Crochet Hook
• 10886705017973: Bristow - Latarjet Instability Shoulder System Coracoid 3.5mm Screw
• 10886705018178: BRISTOW - LATARJET Instability Shoulder System Full Tray
• 10886705017874: Bristow Disposable Kit (Bristow-Latarjet Instability Shoulder System)
• 10886705020720: Bristow - Latarjet Instability Shoulder Screw 48mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020713: Bristow - Latarjet Instability Shoulder Screw 46mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020706: Bristow - Latarjet Instability Shoulder Screw 44mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020690: Bristow - Latarjet Instability Shoulder Screw 42mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020683: Bristow - Latarjet Instability Shoulder Screw 34mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020676: Bristow - Latarjet Instability Shoulder Screw 40mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020669: Bristow - Latarjet Instability Shoulder Screw 32mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020652: Bristow - Latarjet Instability Shoulder Screw 38mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020645: Bristow - Latarjet Instability Shoulder Screw 30mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020638: Bristow - Latarjet Instability Shoulder Screw 36mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705020621: Bristow - Latarjet Instability Shoulder Screw 28mm Titanium Screw & Top Hat; Quanitity: (1) Scre
• 10886705018093: Bristow - Latarjet Instability Shoulder System Glenoid 3.2mm Drill
• 10886705017942: Bristow - Latarjet Instability Shoulder System Coracoid Step Drill
• 10886705017959: Bristow - Latarjet Instability Shoulder System Coracoid Step Tap
• 10886705018215: Bristow - Latarjet Instability Shoulder System Coracoid Drill Guide
• 10886705018192: Bristow - Latarjet Instability Shoulder System Subscapularis Channeler
• 10886705017980: Bristow - Latarjet Instability Shoulder System Coracoid K-Wire