Expandable Lumbar Fusion Cage-Type I

GUDID 06942438518815

Shanghai Reach Medical Instrument Co., Ltd

Metallic spinal interbody fusion cage

• Primary Device ID: 06942438518815
• NIH Device Record Key: dd2b1573-b19e-4f40-95a4-aabf89dbf803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Expandable Lumbar Fusion Cage-Type I
• Version Model Number: F0301-B0024A853
• Company DUNS: 530695344
• Company Name: Shanghai Reach Medical Instrument Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942438518815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232069

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

[06942438518815]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-12
• Device Publish Date: 2024-07-04

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

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