Contour 71337047

GUDID 03596010293299

CONTOUR ACETABULAR REINFORCEMENT RING 47OD 43ID

Smith & Nephew, Inc.

Multi-purpose surgical mesh, metallic

• Primary Device ID: 03596010293299
• NIH Device Record Key: e2bec0d3-cb17-43b9-b374-7c9153bc7069
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contour
• Version Model Number: 71337047
• Catalog Number: 71337047
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• 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
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010293299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211176
• Premarket Notification: K962541

FDA Product Code

• JDJ: Mesh, surgical, acetabular, hip, prosthesis

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: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [Contour]

• 00885556049242: HA CONTOUR ACET RECONSTRUCTION RING 58MM LT
• 00885556048771: HA CONTOUR ACET RECONSTRUCTION RING 52MM LT
• 00885556048610: HA CONTOUR ACET RECONSTRUCTION RING 46MM LT
• 00885556048528: HA CONTOUR ACET RECONSTRUCTION RING 52MM RT
• 00885556048207: HA CONTOUR ACET RECONSTRUCTION RING 46MM RT
• 00885556028599: CONTOUR RECONSTRUCTION RING TRIAL 74OD 70ID LEFT
• 00885556028087: CONTOUR RECON RING TRIAL 68OD 64ID LEFT
• 00885556027363: COMPACTION DOME INSTRUMENT TRAY
• 00885556027219: CONTOUR RECON RING TRIAL 74OD 70ID RIGHT
• 00885556026908: CONTOUR RECONSTRUCTION RING TRIAL 68OD 64ID RIGHT
• 03596010451880: CONTOUR RECONSTRUCTION RING TRIAL 62OD 58ID RIGHT
• 03596010451873: CONTOUR RECONSTRUCTION RING TRIAL 56OD 52ID RIGHT
• 03596010451866: CONTOUR RECONSTRUCTION RING TRIAL 50OD 46ID RIGHT
• 03596010451859: CONTOUR RECONSTRUCTION RING TRIAL 62OD 58ID LEFT
• 03596010451842: CONTOUR RECONSTRUCTION RING TRIAL 56OD 52ID LEFT
• 03596010451835: CONTOUR RECONSTRUCTION RING TRIAL 50OD 46ID LEFT
• 03596010442758: CONTOUR RING INSTRUMENT TRAY
• 03596010329509: CONTOUR FLANGE BENDER
• 03596010293619: CONTOUR ACETABULAR COMPACTION DOME TRAY
• 03596010293305: CONTOUR ACETABULAR REINFORCEMENT RING 50OD 46ID
• 03596010293299: CONTOUR ACETABULAR REINFORCEMENT RING 47OD 43ID
• 03596010293282: CONTOUR ACETABULAR REINFORCEMENT RING 44OD 40ID
• 03596010292087: CONTOUR ACETABULAR REINFORCEMENT RING 68OD 64ID
• 03596010292070: CONTOUR ACETABULAR REINFORCEMENT RING 65OD 61ID
• 03596010292063: CONTOUR ACETABULAR REINFORCEMENT RING 62OD 58ID
• 03596010292056: CONTOUR ACETABULAR REINFORCEMENT RING 59OD 55ID
• 03596010292049: CONTOUR ACETABULAR REINFORCEMENT RING 56OD 52ID
• 03596010292032: CONTOUR ACETABULAR REINFORCEMENT RING 53OD 49ID
• 03596010527332: CONTOUR RECONSTRUCTION RING 68MM OUTER DIAMETER 64MM INNER D
• 03596010527325: CONTOUR RECONSTRUCTION RING 74MM OUTER DIAMETER 70MM INNER D
• 03596010527318: CONTOUR RECONSTRUCTION RING 74MM OUTER DIAMETER 70MM INNER D
• 03596010525178: CONTOUR RECONSTRUCTION RING 68MM OUTER DIAMETER 64MM INNER D
• 03596010378019: CONTOUR REINFORCEMENT TRIAL 68MM OUTER DIAMTER 64MM INNER DI
• 03596010378002: CONTOUR REINFORCEMENT TRIAL 65MM OUTER DIAMTER 61MM INNER DI
• 03596010377999: CONTOUR REINFORCEMENT TRIAL 62MM OUTER DIAMTER 58MM INNER DI
• 03596010377982: CONTOUR REINFORCEMENT TRIAL 59MM OUTER DIAMTER 55MM INNER DI
• 03596010377975: CONTOUR REINFORCEMENT TRIAL 56MM OUTER DIAMTER 52MM INNER DI
• 03596010377968: CONTOUR REINFORCEMENT TRIAL 53MM OUTER DIAMTER 49MM INNER DI
• 03596010377951: CONTOUR REINFORCEMENT TRIAL 50MM OUTER DIAMTER 46MM INNER DI
• 03596010377944: CONTOUR REINFORCEMENT TRIAL 47MM OUTER DIAMTER 43MM INNER DI
• 03596010377937: CONTOUR REINFORCEMENT TRIAL 44MM OUTER DIAMTER 40MM INNER DI
• 03596010308306: CONTOUR ACETABULAR RECONSTRUCTION RING 56MM OUTER DIAMETER 5
• 03596010308290: CONTOUR ACETABULAR RECONSTRUCTION RING 56MM OUTER DIAMETER 5
• 03596010293343: CONTOUR ACETABULAR RECONSTRUCTION RING 62MM OUTER DIAMETER 5
• 03596010293336: CONTOUR ACETABULAR RECONSTRUCTION RING 50MM OUTER DIAMETER 4
• 03596010293329: CONTOUR ACETABULAR RECONSTRUCTION RING 62MM OUTER DIAMETER 5
• 03596010293312: CONTOUR ACETABULAR RECONSTRUCTION RING 50MM OUTER DIAMETER 4
• 03596010609151: CONTOUR COMPACTION DOME 74MM
• 03596010609144: CONTOUR COMPACTION DOME 71MM
• 03596010607386: CONTOUR COMPACTION DOME 59MM