PediatrOS™ FlexTack™ CP20020

GUDID 04048266150387

TiAl6V4 ELI sterile

Merete GmbH

Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: 04048266150387
• NIH Device Record Key: 805dda9b-ebef-4f99-9a4d-673908621220
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediatrOS™ FlexTack™
• Version Model Number: 20
• Catalog Number: CP20020
• Company DUNS: 313267265
• Company Name: Merete GmbH
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: 630-6137182
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com

Device Dimensions

• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266150387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151762

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-11-23
• Device Publish Date: 2016-02-29

On-Brand Devices [PediatrOS™ FlexTack™ ]

• 04048266150387: TiAl6V4 ELI sterile
• 04048266139580: TiAl6V4 ELI sterile
• 04048266138163: TiAl6V4 ELI sterile