72203460

GUDID 00885554028041

OBTURATOR TROC TIP FLEX CRVD GUIDE

Smith & Nephew, Inc.

Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator Surgical drill guide obturator

• Primary Device ID: 00885554028041
• NIH Device Record Key: d241eab9-b0c4-4afa-b237-b25dc3acb06e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 72203460
• Catalog Number: 72203460
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• 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
• 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	00885554028041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103309

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

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

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

[00885554028041]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

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• 00885556919309 - Trigen: 2024-05-30 3.2MM X 343MM SMOOTH ENDED DRILL TIP PIN
• 00885556887165 - PLATINUM: 2024-05-27 PLATINUM MDU BF
• 00885556919033 - R3: 2024-05-24 R3 ANTI-ROTATION TIP W/FLAT SZ58MM
• 00885556918616 - R3: 2024-05-23 SHORT OFFSET ACETABULAR IMPACTOR
• 00885556918623 - R3: 2024-05-23 SZ 42MM BRIDGEBACK REAMER
• 00885556918630 - R3: 2024-05-23 SZ 44MM BRIDGEBACK REAMER
• 00885556918647 - R3: 2024-05-23 SZ 46MM BRIDGEBACK REAMER