281532

GUDID 03596010438423

GELPI RETRACTOR LARGE 191MM LONG

Smith & Nephew, Inc.

Orthopaedic retractor

• Primary Device ID: 03596010438423
• NIH Device Record Key: 9cb1d1c6-ca47-4800-bf04-6378f9ce3117
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 281532
• Catalog Number: 281532
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010438423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121714

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

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

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

[03596010438423]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-10-11
• Device Publish Date: 2015-08-25

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• 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