CASE, OUTER, LID

GUDID 00840311262700

CASE, OUTER, LID

Xtant Medical Holdings, Inc.

Device sterilization/disinfection container, reusable
Primary Device ID00840311262700
NIH Device Record Keya5da235a-7239-4fad-97be-3ee43d313c6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCASE, OUTER, LID
Version Model Number434-224
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840311262700 [Primary]

FDA Product Code

LRPTray, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840311262700]

Moist Heat or Steam Sterilization


[00840311262700]

Moist Heat or Steam Sterilization


[00840311262700]

Moist Heat or Steam Sterilization


[00840311262700]

Moist Heat or Steam Sterilization


[00840311262700]

Moist Heat or Steam Sterilization


[00840311262700]

Moist Heat or Steam Sterilization


[00840311262700]

Moist Heat or Steam Sterilization


[00840311262700]

Moist Heat or Steam Sterilization


[00840311262700]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-19
Device Publish Date2026-02-11

Devices Manufactured by Xtant Medical Holdings, Inc.

00840311262694 - CASE, OUTER, DOUBLE LEVEL2026-02-19 CASE, OUTER, DOUBLE LEVEL
00840311262700 - CASE, OUTER, LID 2026-02-19CASE, OUTER, LID
00840311262700 - CASE, OUTER, LID 2026-02-19 CASE, OUTER, LID
00840311247318 - Fortilink2026-01-30 TiPlus-TC Inserter, Straight
00840311262670 - Cortera Spinal Fixation System2025-12-30 Caddy, Set Screw, 5.5-6.0
00840311262687 - Cortera Spinal Fixation System2025-12-30 Lid, Set Screw, 5.5-6.0
00840311262663 - Streamline TL Spinal Fixation System2025-12-25 Streamline TL, 8.5mm Long Screw Caddy
00840311262632 - Fusion™ Posterior Instrument Set2025-12-19 VBR, Graft Funnel
00840311244713 - Cortera Spinal Fixation System2025-12-18 NAV Instruments Set, ASM

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.