Streamline® MIS Spinal Fixation System

GUDID 00840311245413

Streamline MIS, Cannulated Tap, Ø5.5mm

Xtant Medical Holdings, Inc.

Bone tap, reusable

• Primary Device ID: 00840311245413
• NIH Device Record Key: cb8549fa-2125-4fff-ba93-80760360ac9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline® MIS Spinal Fixation System
• Version Model Number: 04-CANNTAP-55
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, 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: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311245413 [Primary]

FDA Product Code

• HWX: Tap, Bone

Sterilization

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

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-23
• Device Publish Date: 2025-01-15

Devices Manufactured by Xtant Medical Holdings, Inc.

• 00849777013475 - OsteoPore Plus DBM Putty 2.5cc Syringe: 2025-02-27 ONE (1) PACKAGE - CONTAINING 2.5CC
• 00849777013482 - OsteoPore Plus DBM Putty 5.0cc Syringe: 2025-02-27 ONE (1) PACKAGE - CONTAINING 5.0 CC
• 00849777013499 - OsteoPore Plus DBM Putty 10.0cc Syringe: 2025-02-27 ONE (1) PACKAGE - CONTAINING 10.0 CC
• 00849777013444 - OsteoPore Plus DBM Putty 2.5cc Syringe: 2025-02-10 ONE (1) PACKAGE - CONTAINING 2.5CC
• 00849777013451 - OsteoPore Plus DBM Putty 5.0cc Syringe: 2025-02-10 ONE (1) PACKAGE - CONTAINING 5.0CC
• 00849777013468 - OsteoPore Plus DBM Putty 10.0cc Syringe: 2025-02-10 ONE (1) PACKAGE - CONTAINING 10.0CC
• M697T08500191 - Xspan Laminoplasty Fixation System: 2025-01-28 PLATE CUTTER, 9INCH
• M697T08500250 - Xspan Laminoplasty Fixation System: 2025-01-28 Lamina Elevator