Profix 71934898

GUDID 00885556415283

PROFIX CONFORMING PLUS INSERT SZ 2 LT 13MM FOR LEGION BASEPLATE SZ 1-2

Smith & Nephew, Inc.

Tibial insert

• Primary Device ID: 00885556415283
• NIH Device Record Key: 8ea8f8b0-0f63-4811-a593-687d6f97e3ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profix
• Version Model Number: 71934898
• Catalog Number: 71934898
• 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: 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
• 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	00885556415283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946236

FDA Product Code

• KWH: PROSTHESIS, TOE, CONSTRAINED, POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-11-16

On-Brand Devices [Profix]

• 00885556732359: 3 DEGREE TIBIAL CUTTING BLOCK
• 00885556418383: PROFIX CONFORMING PLUS INSERT TRL SZ 5 RT 18MM FOR LEGION BA
• 00885556418338: PROFIX CONFORMING PLUS INSERT TRL SZ 5 RT 15MM FOR LEGION BA
• 00885556418284: PROFIX CONFORMING PLUS INSERT TRL SZ 5 RT 13MM FOR LEGION BA
• 00885556418239: PROFIX CONFORMING PLUS INSERT TRL SZ 5 RT 11MM FOR LEGION BA
• 00885556418185: PROFIX CONFORMING PLUS INSERT TRL SZ 4 RT 18MM FOR LEGION BA
• 00885556418130: PROFIX CONFORMING PLUS INSERT TRL SZ 4 RT 15MM FOR LEGION BA
• 00885556418086: PROFIX CONFORMING PLUS INSERT TRL SZ 4 RT 13MM FOR LEGION BA
• 00885556418031: PROFIX CONFORMING PLUS INSERT TRL SZ 4 RT 11MM FOR LEGION BA
• 00885556417980: PROFIX CONFORMING PLUS INSERT TRL SZ 3 RT 18MM FOR LEGION BA
• 00885556417935: PROFIX CONFORMING PLUS INSERT TRL SZ 3 RT 15MM FOR LEGION BA
• 00885556417881: PROFIX CONFORMING PLUS INSERT TRL SZ 3 RT 13MM FOR LEGION BA
• 00885556417836: PROFIX CONFORMING PLUS INSERT TRL SZ 3 RT 11MM FOR LEGION BA
• 00885556417782: PROFIX CONFORMING PLUS INSERT TRL SZ 2 RT 18MM FOR LEGION BA
• 00885556417737: PROFIX CONFORMING PLUS INSERT TRL SZ 2 RT 15MM FOR LEGION BA
• 00885556417683: PROFIX CONFORMING PLUS INSERT TRL SZ 2 RT 13MM FOR LEGION BA
• 00885556417638: PROFIX CONFORMING PLUS INSERT TRL SZ 2 RT 11MM FOR LEGION BA
• 00885556417584: PROFIX CONFORMING PLUS INSERT TRL SZ 5 LT 18MM FOR LEGION BA
• 00885556417539: PROFIX CONFORMING PLUS INSERT TRL SZ 5 LT 15MM FOR LEGION BA
• 00885556417485: PROFIX CONFORMING PLUS INSERT TRL SZ 5 LT 13MM FOR LEGION BA
• 00885556417430: PROFIX CONFORMING PLUS INSERT TRL SZ 5 LT 11MM FOR LEGION BA
• 00885556417386: PROFIX CONFORMING PLUS INSERT TRL SZ 4 LT 18MM FOR LEGION BA
• 00885556417331: PROFIX CONFORMING PLUS INSERT TRL SZ 4 LT 15MM FOR LEGION BA
• 00885556417287: PROFIX CONFORMING PLUS INSERT TRL SZ 4 LT 13MM FOR LEGION BA
• 00885556417232: PROFIX CONFORMING PLUS INSERT TRL SZ 4 LT 11MM FOR LEGION BA
• 00885556417188: PROFIX CONFORMING PLUS INSERT TRL SZ 3 LT 18MM FOR LEGION BA
• 00885556417133: PROFIX CONFORMING PLUS INSERT TRL SZ 3 LT 15MM FOR LEGION BA
• 00885556417089: PROFIX CONFORMING PLUS INSERT TRL SZ 3 LT 13MM FOR LEGION BA
• 00885556417034: PROFIX CONFORMING PLUS INSERT TRL SZ 3 LT 11MM FOR LEGION BA
• 00885556416983: PROFIX CONFORMING PLUS INSERT TRL SZ 2 LT 18MM FOR LEGION BA
• 00885556416938: PROFIX CONFORMING PLUS INSERT TRL SZ 2 LT 15MM FOR LEGION BA
• 00885556416884: PROFIX CONFORMING PLUS INSERT TRL SZ 2 LT 13MM FOR LEGION BA
• 00885556416839: PROFIX CONFORMING PLUS INSERT TRL SZ 2 LT 11MM FOR LEGION BA
• 00885556416785: PROFIX CONFORMING PLUS INSERT SZ 5 RT 18MM FOR LEGION BASEPL
• 00885556416730: PROFIX CONFORMING PLUS INSERT SZ 5 RT 15MM FOR LEGION BASEPL
• 00885556416686: PROFIX CONFORMING PLUS INSERT SZ 5 RT 13MM FOR LEGION BASEPL
• 00885556416631: PROFIX CONFORMING PLUS INSERT SZ 5 RT 11MM FOR LEGION BASEPL
• 00885556416587: PROFIX CONFORMING PLUS INSERT SZ 4 RT 18MM FOR LEGION BASEPL
• 00885556416532: PROFIX CONFORMING PLUS INSERT SZ 4 RT 15MM FOR LEGION BASEPL
• 00885556416488: PROFIX CONFORMING PLUS INSERT SZ 4 RT 13MM FOR LEGION BASEPL
• 00885556416433: PROFIX CONFORMING PLUS INSERT SZ 4 RT 11MM FOR LEGION BASEPL
• 00885556416389: PROFIX CONFORMING PLUS INSERT SZ 3 RT 18MM FOR LEGION BASEPL
• 00885556416334: PROFIX CONFORMING PLUS INSERT SZ 3 RT 15MM FOR LEGION BASEPL
• 00885556416280: PROFIX CONFORMING PLUS INSERT SZ 3 RT 13MM FOR LEGION BASEPL
• 00885556416235: PROFIX CONFORMING PLUS INSERT SZ 3 RT 11MM FOR LEGION BASEPL
• 00885556416181: PROFIX CONFORMING PLUS INSERT SZ 2 RT 18MM FOR LEGION BASEPL
• 00885556416136: PROFIX CONFORMING PLUS INSERT SZ 2 RT 15MM FOR LEGION BASEPL
• 00885556416082: PROFIX CONFORMING PLUS INSERT SZ 2 RT 13MM FOR LEGION BASEPL
• 00885556416037: PROFIX CONFORMING PLUS INSERT SZ 2 RT 11MM FOR LEGION BASEPL
• 00885556415986: PROFIX CONFORMING PLUS INSERT SZ 5 LT 18MM FOR LEGION BASEPL