SERENGETI® MI Retractor System PRO-1130-04

GUDID 10888857583283

Gelpi Retractor 70 mm, L

K2M, INC.

Self-retaining surgical retractor, reusable

• Primary Device ID: 10888857583283
• NIH Device Record Key: b77d251c-0aac-4b67-9825-088aecf3660b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SERENGETI® MI Retractor System
• Version Model Number: PRO-1130-04
• Catalog Number: PRO-1130-04
• Company DUNS: 146060863
• Company Name: K2M, 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(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857583283 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

[10888857583283]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-17
• Device Publish Date: 2025-02-07

On-Brand Devices [SERENGETI® MI Retractor System]

• 10888857001183: Pedicle Access Needle, Beveled Size 11G
• 10888857000926: Perfect Scalpel™ Ø1.3 mm Cannula
• 10888857583283: Gelpi Retractor 70 mm, L
• 10888857583276: Gelpi Retractor 70 mm, R
• 10888857583269: Gelpi Retractor 100 mm, L
• 10888857583252: Gelpi Retractor 100 mm, R