N/A PPE-117S

GUDID 08809517539032

Modified Pectus Bar - Serrated end *17.0Inch, (431.8mm)

TDM Co., Ltd.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08809517539032
• NIH Device Record Key: 59eb2c86-f6ce-4732-9ff2-51b6ed314f5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: PPE-117S
• Catalog Number: PPE-117S
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch
• Length: 17 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809517539032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191057

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

[08809517539032]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-22
• Device Publish Date: 2020-05-14

On-Brand Devices [N/A]

• 08809319846369: 2.0mm Cortical Screw*6mm
• 08809319841913: 2.0mm Cortical Screw*20mm
• 08809319841906: 2.0mm Cortical Screw*18mm
• 08809319841890: 2.0mm Cortical Screw*16mm
• 08809319841883: 2.0mm Cortical Screw*14mm
• 08809319841876: 2.0mm Cortical Screw*12mm
• 08809319841869: 220-21010
• 08809319841852: 2.0mm Cortical Screw*8mm
• 08809517537236: Clavicle Locking Plate, Mid Shaft *Rt/6H
• 08809517537229: Clavicle Locking Plate, Mid Shaft *Rt/5H
• 08809517537212: Clavicle Locking Plate, Mid Shaft *Lt/6H
• 08809517537205: Clavicle Locking Plate, Mid Shaft *Lt/5H
• 08809517536994: Distal Tibia Locking Plate, Medial, Hook *4H
• 08809517536987: Distal Tibia Locking Plate, Medial, Hook *3H
• 08809517536963: Clavicle Locking Plate, Distal *Rt/7H
• 08809517536956: Clavicle Locking Plate, Distal *Rt/6H
• 08809517536949: Clavicle Locking Plate, Distal *Lt/7H
• 08809517536932: Clavicle Locking Plate, Distal *Lt/6H
• 08809517536482: Distal Tibia Locking Plate, Medial *4H
• 08809517536475: Distal Tibia Locking Plate, Medial *3H
• 08809517536468: Fibular Locking Plate, Lateral *Rt/7H
• 08809517536451: Fibular Locking Plate, Lateral *Rt/5H
• 08809517536444: Fibular Locking Plate, Lateral *Rt/4H
• 08809517536437: Fibular Locking Plate, Lateral *Rt/3H
• 08809517536420: Fibular Locking Plate, Lateral *Lt/7H
• 08809517536413: Fibular Locking Plate, Lateral *Lt/5H
• 08809517536406: Fibular Locking Plate, Lateral *Lt/4H
• 08809517536390: Fibular Locking Plate, Lateral *Lt/3H
• 08809517536345: Distal Tibia Locking Plate, Anterior *Rt/6H
• 08809517536338: Distal Tibia Locking Plate, Anterior *Rt/5H
• 08809517536321: Distal Tibia Locking Plate, Anterior *Rt/4H
• 08809517536314: Distal Tibia Locking Plate, Anterior *Rt/3H
• 08809517536307: Distal Tibia Locking Plate, Anterior *Lt/6H
• 08809517536291: Distal Tibia Locking Plate, Anterior *Lt/5H
• 08809517536284: Distal Tibia Locking Plate, Anterior *Lt/4H
• 08809517536277: Distal Tibia Locking Plate, Anterior *Lt/3H
• 08809517535812: Fibular Locking Plate, Posterior *Rt/5H
• 08809517535805: Fibular Locking Plate, Posterior *Rt/4H
• 08809517535799: Fibular Locking Plate, Posterior *Rt/3H
• 08809517535782: Fibular Locking Plate, Posterior *Lt/5H
• 08809517535775: Fibular Locking Plate, Posterior *Lt/4H
• 08809517535768: Fibular Locking Plate, Posterior *Lt/3H
• 08809517535621: Clavicle Locking Plate, Distal Hook *Rt/3H, 12mm
• 08809517535614: Clavicle Locking Plate, Distal Hook *Lt/3H, 12mm
• 08809517535607: Clavicle Locking Plate, Distal Hook *Rt/4H, 18mm
• 08809517535591: Clavicle Locking Plate, Distal Hook *Lt/4H, 18mm
• 08809517535584: Clavicle Locking Plate, Distal Hook *Rt/3H, 18mm
• 08809517535577: Clavicle Locking Plate, Distal Hook *Lt/3H, 15mm
• 08809517535560: Clavicle Locking Plate, Distal Hook *Lt/3H, 18mm
• 08809517535478: Clavicle Locking Plate, Anterior *8H