Trauma - Misc E0015743-2

GUDID 00885556705636

3.2MM X 450MM DRILL TIP GUIDE PINS

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00885556705636
• NIH Device Record Key: ac973091-b739-48d6-a28d-b3df3d19da3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trauma - Misc
• Version Model Number: E0015743-2
• Catalog Number: E0015743-2
• 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
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556705636 [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

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

[00885556705636]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-02

On-Brand Devices [Trauma - Misc]

• 00885556739297: 205MM FORCEPS W/ BALL TIP
• 00885556739181: MODIFIED BLOCKING SCREW GUIDE
• 00885556726303: CANNULATED DEPTH GAUGE
• 00885556724835: 1.9MM X 300MM NON-THREADED GUIDE PIN
• 00885556721049: 1.9MM X 450MM GUIDE PIN
• 00885556719077: 3.2MM X 343MM SMOOTH ENDED DRILL TIP PIN
• 00885556719053: 1.9MM X 300MM NON-THREADED GUIDE PIN
• 00885556717585: CANNULATED DEPTH GAUGE
• 00885556717578: 3.2MM X 450MM DRILL TIP GUIDE PIN
• 00885556717561: CANNULATED DEPTH GAUGE
• 00885556717554: 3.2MM X 450MM DRILL TIP GUIDE PIN
• 00885556717455: MODIFIED BLOCKING SCREW GUIDE
• 00885556714249: MODIFIED 3.2MM PARALLEL PIN GUIDE
• 00885556709320: CANNULATED DEPTH GAUGE
• 00885556705636: 3.2MM X 450MM DRILL TIP GUIDE PINS
• 00885556705629: CANNULATED DEPTH GAUGE
• 00885556705612: 3.2MM X 450MM DRILL TIP GUIDE PINS
• 00885556705605: CANNULATED DEPTH GAUGE
• 00885556705537: 2.5MM HEX DRIVER WITH LARGE HANDLE
• 00885556744963: 3.4MM HEX DRIVER W/ HANDLE
• 00885556744956: 2.7MM HEX DRIVER W/ HANDLE
• 00885556748558: MODIFIED 6.5MM CANNULATED SCREW DRIVER
• 00885556774656: 205MM FORCEPS W/ BALL TIP
• 00885556789711: LARGE BENDING PRESS LOWER ANVIL
• 00885556789704: LARGE BENDING PRESS UPPER ANVIL
• 00885556791325: MODIFIED BLOCKING SCREW GUIDE
• 00885556794630: MODIFIED 6.5MM CANNULATED SCREW DRIVER
• 00885556871331: 2.5MM TARGETER DRILL BIT
• 00885556799291: EXTENDED T8 DRIVER SHAFT
• 00885556799284: EXTENDED T7 DRIVER SHAFT
• 00885556799277: EXTENDED T6 DRIVER SHAFT