SERENGETI® MI Retractor System 1001-90112-SG

GUDID 10888857000926

Perfect Scalpel™ Ø1.3 mm Cannula

K2M, INC.

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10888857000926
• NIH Device Record Key: b16e60dc-92b2-46d2-945f-7fa100e1bc9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SERENGETI® MI Retractor System
• Version Model Number: 1001-90112-SG
• Catalog Number: 1001-90112-SG
• 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: 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(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	10888857000926 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-24
• Device Publish Date: 2022-10-14

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