OR3O Dual Mobility 71353304

GUDID 00885556710470

OR3O DUAL MOBILITY TRIAL LINER 42/54

Smith & Nephew, Inc.

Femoral head prosthesis trial

• Primary Device ID: 00885556710470
• NIH Device Record Key: b0e5a32a-caf6-4fc6-babd-738a5f2a3142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OR3O Dual Mobility
• Version Model Number: 71353304
• Catalog Number: 71353304
• 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)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	00885556710470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191002

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

[00885556710470]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-03
• Device Publish Date: 2019-11-25

On-Brand Devices [OR3O Dual Mobility]

• 00885556710661: OR3O DUAL MOBILITY TRIAL INSERT 28/54
• 00885556710654: OR3O DUAL MOBILITY TRIAL INSERT 28/52
• 00885556710647: OR3O DUAL MOBILITY TRIAL INSERT 28/50
• 00885556710630: OR3O DUAL MOBILITY TRIAL INSERT 28/48
• 00885556710623: OR3O DUAL MOBILITY TRIAL INSERT 28/46
• 00885556710616: OR3O DUAL MOBILITY TRIAL INSERT 28/44
• 00885556710609: OR3O DUAL MOBILITY TRIAL INSERT 28/42
• 00885556710586: OR3O DUAL MOBILITY TRIAL INSERT 22/40
• 00885556710562: OR3O DUAL MOBILITY TRIAL INSERT 22/38
• 00885556710555: OR3O DUAL MOBILITY TRIAL INSERT 22/36
• 00885556712429: OR3O DUAL MOBILITY XLPE INSERT 28/52
• 00885556712412: OR3O DUAL MOBILITY XLPE INSERT 28/50
• 00885556712405: OR3O DUAL MOBILITY XLPE INSERT 28/48
• 00885556712399: OR3O DUAL MOBILITY XLPE INSERT 28/46
• 00885556712382: OR3O DUAL MOBILITY XLPE INSERT 28/44
• 00885556712375: OR3O DUAL MOBILITY XLPE INSERT 28/42
• 00885556712351: OR3O DUAL MOBILITY XLPE INSERT 22/40
• 00885556712344: OR3O DUAL MOBILITY XLPE INSERT 22/38
• 00885556712337: OR3O DUAL MOBILITY XLPE INSERT 22/36
• 00885556712313: OR3O DUAL MOBILITY LINER 52/66-70
• 00885556712306: OR3O DUAL MOBILITY LINER 50/64
• 00885556712290: OR3O DUAL MOBILITY LINER 48/62
• 00885556712283: OR3O DUAL MOBILITY LINER 46/60
• 00885556712276: OR3O DUAL MOBILITY LINER 44/58
• 00885556712269: OR3O DUAL MOBILITY LINER 44/56
• 00885556712252: OR3O DUAL MOBILITY LINER 42/54
• 00885556712245: OR3O DUAL MOBILITY LINER 40/52
• 00885556712238: OR3O DUAL MOBILITY LINER 38/50
• 00885556712221: OR3O DUAL MOBILITY LINER 36/48
• 00885556710548: OR3O DUAL MOBILITY TRIAL LINER 54/72-74
• 00885556710531: OR3O DUAL MOBILITY TRIAL LINER 52/66-70
• 00885556710524: OR3O DUAL MOBILITY TRIAL LINER 50/64
• 00885556710517: OR3O DUAL MOBILITY TRIAL LINER 48/62
• 00885556710500: OR3O DUAL MOBILITY TRIAL LINER 46/60
• 00885556710494: OR3O DUAL MOBILITY TRIAL LINER 44/58
• 00885556710487: OR3O DUAL MOBILITY TRIAL LINER 44/56
• 00885556710470: OR3O DUAL MOBILITY TRIAL LINER 42/54
• 00885556710463: OR3O DUAL MOBILITY TRIAL LINER 40/52
• 00885556710456: OR3O DUAL MOBILITY TRIAL LINER 38/50
• 00885556710449: OR3O DUAL MOBILITY TRIAL LINER 36/48
• 00885556712320: OR3O DUAL MOBILITY LINER 54/72-74
• 00885556800874: OR3O DUAL MOBILITY XLPE INSERT 22/34
• 00885556800867: OR3O DUAL MOBILITY XLPE INSERT 22/32
• 00885556800850: OR3O DUAL MOBILITY LINER 34/46
• 00885556800843: OR3O DUAL MOBILITY LINER 32/44
• 00885556724897: OR3O DUAL MOBILITY XLPE INSERT 28/38
• 00885556712368: OR3O DUAL MOBILITY XLPE INSERT 28/40
• 00885556800911: OR3O DUAL MOBILITY TRIAL LINER 32/44
• 00885556800904: OR3O DUAL MOBILITY TRIAL LINER 34/46
• 00885556800898: OR3O DUAL MOBILITY TRIAL INSERT 22/32