STREAMLINE OCT

GUDID 00840311257928

HANDHELD RATCHETING ROD CUTTER

Xtant Medical Holdings, Inc.

Orthopaedic implantable-device cutter
Primary Device ID00840311257928
NIH Device Record Keyc04a625a-73ca-4a2a-b7d8-46b86868eddf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTREAMLINE OCT
Version Model NumberC999-000004
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840311257928 [Primary]

FDA Product Code

FZTCutter, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


[00840311257928]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-19
Device Publish Date2025-08-11

Devices Manufactured by Xtant Medical Holdings, Inc.

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00840311233007 - CONTACT ALP Anterior Lumbar Plate System2026-03-19 Temporary Holding Pin, Push Style, Lumbar / Sacral Plate
00840311233014 - CONTACT ALP Anterior Lumbar Plate System2026-03-19 Temporary Holding Pin, Push Style, 25MM, Lumbar / Sacral Plate
M697X00310040 - Calix-C Cervical Interbody Spacer2026-03-18 Lordotic Caddy, Calix Cervical
M697X03422130 - Calix Lumbar Spinal Implant System2026-03-18 Calix-T Implant Caddy
00840311262694 - CASE, OUTER, DOUBLE LEVEL2026-02-19 CASE, OUTER, DOUBLE LEVEL
00840311262700 - CASE, OUTER, LID 2026-02-19 CASE, OUTER, LID
00840311247318 - Fortilink2026-01-30 TiPlus-TC Inserter, Straight

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