Internal Fix E0016931-1

GUDID 00885556779972

CANNULATED DEPTH GAUGE

Smith & Nephew, Inc.

Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable

• Primary Device ID: 00885556779972
• NIH Device Record Key: 2ff42c96-a73f-4b84-9cea-b23c4f18e23a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Internal Fix
• Version Model Number: E0016931-1
• Catalog Number: E0016931-1
• Company DUNS: 109903521
• Company Name: Smith & Nephew, 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: false
• 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556779972 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123055

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

[00885556779972]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-26
• Device Publish Date: 2020-03-18

On-Brand Devices [Internal Fix]

• 00885556778920: 2.5MM HEX TARGETER DRIVER
• 00885556778913: 2.5MM TARGETER DRILL BIT
• 00885556778906: 3.5MM TARGETER DEPTH GAUGE
• 00885556778890: 2.5MM TARGETER DRILL GUIDE
• 00885556779972: CANNULATED DEPTH GAUGE
• 00885556773840: GUIDE PIN SLEEVE - STRAIGHT HANDLE
• 00885556794593: EXTENDED T8 DRIVER SHAFT
• 00885556794586: EXTENDED T7 DRIVER SHAFT
• 00885556794579: EXTENDED T6 DRIVER SHAFT
• 00885556794340: CABLE PASSER - LARGE
• 00885556794333: CABLE PASSER - SMALL
• 00885556802496: PLATE BENDING PLIERS - 2.7
• 00885556802489: PLATE BENDING PLIERS - 2.4
• 00885556802472: PLATE BENDING PLIERS - 2.0
• 00885556802519: PLATE BENDING PLIERS - 2.0
• 00885556802533: PLATE BENDING PLIERS - 2.7
• 00885556802526: PLATE BENDING PLIERS - 2.4
• 00885556804698: 3.5MM TARGETER DEPTH GAUGE
• 00885556804681: EXTRA LONG 2.5MM HEX TARGETER DRIVER
• 00885556879085: 2.5MM PUSH SCREW SLEEVE
• 00885556879078: 2.5MM SHORT PUSH SCREW SHAFT
• 00885556886311: EXTENDED T6 LINEAR DRIVER SHAFT
• 00885556886304: EXTENDED T8 HOLDING SLEEVE
• 00885556886298: EXTENDED T7 HOLDING SLEEVE
• 00885556886281: EXTENDED T6 HOLDING SLEEVE
• 00885556886335: EXTENDED T8 LINEAR DRIVER SHAFT
• 00885556886328: EXTENDED T7 LINEAR DRIVER SHAFT