ULTRABUTTON 72290003

GUDID 00885556613825

ULTRABUTTON ADJUSTABLE FIXATION DEVICE

Smith & Nephew, Inc.

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• Primary Device ID: 00885556613825
• NIH Device Record Key: 4c59473c-12c1-4d59-b1c4-1f27a0b9c6b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRABUTTON
• Version Model Number: 72290003
• Catalog Number: 72290003
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: true
• 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	00885556613825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153186

FDA Product Code

• MBI: Fastener, fixation, nondegradable, soft tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2017-04-05

On-Brand Devices [ULTRABUTTON]

• 00885556613825: ULTRABUTTON ADJUSTABLE FIXATION DEVICE
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• 00885556817216: ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, MEDIUM
• 00885556817209: ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, SMALL
• 00885556817193: ULTRABUTTON BB BONE BLOCK ADJUSTABLE FIXATION DEVICE
• 00885556817179: ULTRABUTTON QUAD ADJUSTABLE FIXATION DEVICE