Polar Stem E0015677-1

GUDID 00885556704684

MODULAR POLAR BOX OSTEOTOME

Smith & Nephew, Inc.

Orthopaedic osteotome

• Primary Device ID: 00885556704684
• NIH Device Record Key: 528d3332-19d5-45d5-ad71-7d56fcc30af5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polar Stem
• Version Model Number: E0015677-1
• Catalog Number: E0015677-1
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556704684 [Primary]

FDA Product Code

• HWM: OSTEOTOME

Sterilization

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

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

[00885556704684]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-11

On-Brand Devices [Polar Stem]

• 00885556704684: MODULAR POLAR BOX OSTEOTOME
• 00885556704677: OFFSET POLAR STEM INSERTER