REDAPT 71354557

GUDID 00885556324547

REDAPT 0 Degree Cemented XLPE Liner 44MM X 64MM

Smith & Nephew, Inc.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00885556324547
• NIH Device Record Key: cb41a9c2-0d48-4150-a5cb-e1134b8dfbc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REDAPT
• Version Model Number: 71354557
• Catalog Number: 71354557
• 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
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556324547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150790

FDA Product Code

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

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: 2016-04-19

On-Brand Devices [REDAPT]

• 00885556740859: REDAPT EXTENDED REAMER REMOVAL CAP
• 00885556715291: EXTENDED REAMER QUICK CONNECT
• 00885556685631: REDAPT Slice Augment 56MM x 12MM
• 00885556668733: REDAPT Slice Augment 50MM X 12MM
• 00885556657966: REDAPT MODULAR SHELL 80MM
• 00885556657959: REDAPT MODULAR SHELL 78MM
• 00885556657942: REDAPT MODULAR SHELL 76MM
• 00885556657935: REDAPT MODULAR SHELL 74MM
• 00885556657928: REDAPT MODULAR SHELL 72MM
• 00885556657911: REDAPT MODULAR SHELL 70MM
• 00885556657904: REDAPT MODULAR SHELL 68MM
• 00885556657898: REDAPT MODULAR SHELL 66MM
• 00885556657881: REDAPT MODULAR SHELL 64MM
• 00885556657874: REDAPT MODULAR SHELL 62MM
• 00885556657867: REDAPT MODULAR SHELL 60MM
• 00885556657850: REDAPT MODULAR SHELL 58MM
• 00885556657843: REDAPT MODULAR SHELL 56MM
• 00885556657836: REDAPT MODULAR SHELL 54MM
• 00885556657812: REDAPT MODULAR SHELL 52MM
• 00885556657805: REDAPT MODULAR SHELL 50MM
• 00885556657799: REDAPT MODULAR SHELL 48MM
• 00885556647356: EXTENDED REAMER REMOVAL CAP
• 00885556645987: REDAPT STAPLE AUGMENT TRIAL 50 X 8
• 00885556587614: REDAPT REV ACET STAPLE AUGMENT TRIALS TRAY
• 00885556587607: REDAPT REV ACET SLICE AUGMENT TRIALS TRAY
• 00885556587584: REDAPT STRAIGHT SHAFT DRILL 50MM
• 00885556587577: REDAPT STRAIGHT SHAFT DRILL 35MM
• 00885556587560: REDAPT STRAIGHT SHAFT DRILL 25MM
• 00885556587553: REDAPT STRAIGHT SHAFT DRILL 15MM
• 00885556587539: REDAPT Augment Holding Forceps
• 00885556586082: REDAPT STAPLE AUGMENT TRIAL 74 X 24
• 00885556586075: REDAPT STAPLE AUGMENT TRIAL 68 X 24
• 00885556586068: REDAPT STAPLE AUGMENT TRIAL 62 X 24
• 00885556586051: REDAPT STAPLE AUGMENT TRIAL 56 X 24
• 00885556586044: REDAPT STAPLE AUGMENT TRIAL 50 X 24
• 00885556586037: REDAPT STAPLE AUGMENT TRIAL 74 X 18
• 00885556586020: REDAPT STAPLE AUGMENT TRIAL 68 X 18
• 00885556586013: REDAPT STAPLE AUGMENT TRIAL 62 X 18
• 00885556586006: REDAPT STAPLE AUGMENT TRIAL 56 X 18
• 00885556585993: REDAPT STAPLE AUGMENT TRIAL 50 X 18
• 00885556585986: REDAPT STAPLE AUGMENT TRIAL 74 X 12
• 00885556585979: REDAPT STAPLE AUGMENT TRIAL 68 X 12
• 00885556585962: REDAPT STAPLE AUGMENT TRIAL 62 X 12
• 00885556585955: REDAPT STAPLE AUGMENT TRIAL 56 X 12
• 00885556585948: REDAPT STAPLE AUGMENT TRIAL 50 X 12
• 00885556585931: REDAPT STAPLE AUGMENT TRIAL 74 X 8
• 00885556585924: REDAPT STAPLE AUGMENT TRIAL 68 X 8
• 00885556585917: REDAPT STAPLE AUGMENT TRIAL 62 X 8
• 00885556585900: REDAPT STAPLE AUGMENT TRIAL 56 X 8
• 00885556585894: REDAPT SLICE AUGMENT TRIAL 74 X 24