ANTHEM 71422683

GUDID 00885556583821

ANTHEM PS HI-FLEX INSERT SIZE 7-8 13MM

Smith & Nephew, Inc.

Tibial insert

• Primary Device ID: 00885556583821
• NIH Device Record Key: ca58a1d8-01c8-4f01-a0d3-e9ef7b409aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTHEM
• Version Model Number: 71422683
• Catalog Number: 71422683
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556583821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032295

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-09

On-Brand Devices [ANTHEM]

• 00885556656150: ANTHEM CR HI-FLEX INSERT SIZE 7-8 18MM
• 00885556656143: ANTHEM CR HI-FLEX INSERT SIZE 7-8 15MM
• 00885556656136: ANTHEM CR HI-FLEX INSERT SIZE 7-8 13MM
• 00885556656129: ANTHEM CR HI-FLEX INSERT SIZE 7-8 11MM
• 00885556656112: ANTHEM CR HI-FLEX INSERT SIZE 7-8 9MM
• 00885556656105: ANTHEM CR HI-FLEX INSERT SIZE 5-6 18MM
• 00885556656099: ANTHEM CR HI-FLEX INSERT SIZE 5-6 15MM
• 00885556656082: ANTHEM CR HI-FLEX INSERT SIZE 5-6 13MM
• 00885556656075: ANTHEM CR HI-FLEX INSERT SIZE 5-6 11MM
• 00885556656068: ANTHEM CR HI-FLEX INSERT SIZE 5-6 9MM
• 00885556656051: ANTHEM CR HI-FLEX INSERT SIZE 3-4 18MM
• 00885556656044: ANTHEM CR HI-FLEX INSERT SIZE 3-4 15MM
• 00885556656037: ANTHEM CR HI-FLEX INSERT SIZE 3-4 13MM
• 00885556656020: ANTHEM CR HI-FLEX INSERT SIZE 3-4 11MM
• 00885556656013: ANTHEM CR HI-FLEX INSERT SIZE 3-4 9MM
• 00885556656006: ANTHEM CR HI-FLEX INSERT SIZE 1-2 18MM
• 00885556655993: ANTHEM CR HI-FLEX INSERT SIZE 1-2 15MM
• 00885556655986: ANTHEM CR HI-FLEX INSERT SIZE 1-2 13MM
• 00885556655979: ANTHEM CR HI-FLEX INSERT SIZE 1-2 11MM
• 00885556655962: ANTHEM CR HI-FLEX INSERT SIZE 1-2 9MM
• 00885556655955: ANTHEM FEMORAL CR COCR SIZE 8 RT
• 00885556655948: ANTHEM FEMORAL CR COCR SIZE 7 RT
• 00885556655931: ANTHEM FEMORAL CR COCR SIZE 6 RT
• 00885556655924: ANTHEM FEMORAL CR COCR SIZE 5 RT
• 00885556655917: ANTHEM FEMORAL CR COCR SIZE 4 RT
• 00885556655900: ANTHEM FEMORAL CR COCR SIZE 3 RT
• 00885556655894: ANTHEM FEMORAL CR COCR SIZE 6 RIGHT N
• 00885556655887: ANTHEM FEMORAL CR COCR SIZE 5 RIGHT N
• 00885556655870: ANTHEM FEMORAL CR COCR SIZE 4 RIGHT N
• 00885556655863: ANTHEM FEMORAL CR COCR SIZE 3 RIGHT N
• 00885556655856: ANTHEM FEMORAL CR COCR SIZE 2 RIGHT N
• 00885556655849: ANTHEM FEMORAL CR COCR SIZE 1 RIGHT N
• 00885556655832: ANTHEM FEMORAL CR COCR SIZE 8 LEFT
• 00885556655825: ANTHEM FEMORAL CR COCR SIZE 7 LEFT
• 00885556655818: ANTHEM FEMORAL CR COCR SIZE 6 LEFT
• 00885556655801: ANTHEM FEMORAL CR COCR SIZE 5 LEFT
• 00885556655795: ANTHEM FEMORAL CR COCR SIZE 4 LEFT
• 00885556655788: ANTHEM FEMORAL CR COCR SIZE 3 LEFT
• 00885556655771: ANTHEM FEMORAL CR COCR SIZE 6 LEFT N
• 00885556655764: ANTHEM FEMORAL CR COCR SIZE 5 LEFT N
• 00885556655757: ANTHEM FEMORAL CR COCR SIZE 4 LEFT N
• 00885556655740: ANTHEM FEMORAL CR COCR SIZE 3 LEFT N
• 00885556655733: ANTHEM FEMORAL CR COCR SIZE 2 LEFT N
• 00885556655726: ANTHEM FEMORAL CR COCR SIZE 1 LEFT N
• 00885556618134: ORTHOMATCH FEM/TIB OUTLIER TRAY SZ 7-8
• 00885556613535: ANTHEM FEMORAL TRIALS L PANEL SZ 1-6
• 00885556613504: ORTHOMATCH PS PREP PANEL SZ 1-8
• 00885556613498: ORTHOMATCH FEM PREP & TRIALS TRAY SZ 1-6
• 00885556613481: ORTHOMATCH FEM PREP TRAY SZ 1-6
• 00885556613474: ANTHEM FEM TRIAL OUTLIER PANEL SZ 7-8