N/A13 137-14309

GUDID 08800043906596

DRLP, Intra Articular, Small *Rt/9H

TDM Co., Ltd.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800043906596
• NIH Device Record Key: c4c83421-a8d6-441a-8946-e61355589a7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A13
• Version Model Number: 137-14309
• Catalog Number: 137-14309
• Company DUNS: 557801921
• Company Name: TDM Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800043906596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190391

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

[08800043906596]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-10-06
• Device Publish Date: 2019-11-25

Devices Manufactured by TDM Co., Ltd.

• 08800043905018 - N/A: 2024-08-16 5.0mm Locking Screw, 84mm
• 08800043909917 - N/A: 2024-08-16 6.5mm Cannulated Cancellous Locking Screw, Star, 30mm
• 08800043909924 - N/A: 2024-08-16 6.5mm Cannulated Cancellous Locking Screw, Star, 100mm
• 08800043909948 - N/A: 2024-08-16 6.5mm Cancellous Locking Screw, Star, 100mm
• 08800043910708 - N/A: 2024-08-16 6.5mm Cannulated Cancellous Locking Screw, Star, 32mm
• 08800043910715 - N/A: 2024-08-16 6.5mm Cannulated Cancellous Locking Screw, Star, 35mm
• 08800043910722 - N/A: 2024-08-16 6.5mm Cannulated Cancellous Locking Screw, Star, 40mm
• 08800043910739 - N/A: 2024-08-16 6.5mm Cannulated Cancellous Locking Screw, Star, 45mm