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.

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• 00885556906590 - EVOS: 2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 5 HOLE
• 00885556906606 - EVOS: 2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 6 HOLE
• 00885556906613 - EVOS: 2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 7 HOLE
• 00885556906620 - EVOS: 2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 8 HOLE
• 00885556906637 - EVOS: 2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 10 HOLE
• 00885556906644 - EVOS: 2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 12 HOLE
• 00885556906651 - EVOS: 2025-09-26 EVOS PELVIC 3.5MM NON-LOCKING STRAIGHT RECON PLATE FLEX 14 HOLE