120709

GUDID 03596010061140

ACETABULAR CEMENT RESTRICTOR POLYETHYLENE LARGE 38.10MM

Smith & Nephew, Inc.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 03596010061140
• NIH Device Record Key: a55674d1-281a-46eb-aca2-31c05c72a0e0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 120709
• Catalog Number: 120709
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010061140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791125

FDA Product Code

• LZN: CEMENT OBTURATOR

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: 2020-11-03
• Device Publish Date: 2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

• 00885556917442 - CORIOGRAPH: 2024-11-15 CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE
• 00885556919620 - R3: 2024-11-14 R3 HEX ADAPTER
• 00885556919637 - R3: 2024-11-14 MAGNETIC T-HANDLE SOCKET WRENCH
• 00885556919613 - R3: 2024-11-12 OFFSET CUP IMPACTOR
• 00885556000908 - Legion: 2024-11-05 1 Degree Varus/Valgus Recut Block
• 00885556000915 - Legion: 2024-11-05 2 Degree Varus/Valgus Recut Block
• 00885556920640 - NA: 2024-11-05 4.5mm Proximal Tibia Plate 4 Hole EVOS
• 00885556920831 - Legion: 2024-11-05 Monolithic CR DF Trial Sz 3-4 - 18mm