Expandable Lumbar Fusion Cage-Type I

GUDID 06942438535683

Shanghai Reach Medical Instrument Co., Ltd

Metallic spinal interbody fusion cage
Primary Device ID06942438535683
NIH Device Record Key5ded3c35-cef5-4c26-bcb7-e95d47b7b527
Commercial Distribution StatusIn Commercial Distribution
Brand NameExpandable Lumbar Fusion Cage-Type I
Version Model NumberF0301-B0024AC5F
Company DUNS530695344
Company NameShanghai Reach Medical Instrument Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106942438535683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


[06942438535683]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-12
Device Publish Date2024-07-04

On-Brand Devices [Expandable Lumbar Fusion Cage-Type I]

06942438535768F0301-B0032AE5F
06942438535751F0301-B0032AC5C
06942438535744F0301-B0032AB59
06942438535737F0301-B0024AA59
06942438535720F0301-B0032AA56
06942438535713F0301-B0032A853
06942438535706F0301-B0028AD5F
06942438535690F0301-B0028AC5C
06942438535683F0301-B0024AC5F
06942438535676F0301-B0024AB5C
06942438523895F0301-B0028AB59
06942438523888F0301-B0028A956
06942438523871F0301-B0024A956
06942438518822F0301-B0028A853
06942438518815F0301-B0024A853

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.