OsteoBridge™ Interlocking screw GB35044

GUDID 04048266000712

TiAl6V4 ELI non-sterile

Merete GmbH

Diaphysis prosthesis

• Primary Device ID: 04048266000712
• NIH Device Record Key: 4fec960f-f4a2-483d-8c96-74de5348ed9f
• Commercial Distribution Discontinuation: 2020-02-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OsteoBridge™ Interlocking screw
• Version Model Number: 5.0 44
• Catalog Number: GB35044
• 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: false
• 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: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• 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
• 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
• 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

• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266000712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051965

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

[04048266000712]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-12
• Device Publish Date: 2015-10-15

On-Brand Devices [OsteoBridge™ Interlocking screw]

• 04048266000774: TiAl6V4 ELI non-sterile
• 04048266000767: TiAl6V4 ELI non-sterile
• 04048266000750: TiAl6V4 ELI non-sterile
• 04048266000743: TiAl6V4 ELI non-sterile
• 04048266000736: TiAl6V4 ELI non-sterile
• 04048266000729: TiAl6V4 ELI non-sterile
• 04048266000712: TiAl6V4 ELI non-sterile
• 04048266000705: TiAl6V4 ELI non-sterile
• 04048266000699: TiAl6V4 ELI non-sterile
• 04048266000682: TiAl6V4 ELI non-sterile
• 04048266000675: TiAl6V4 ELI non-sterile
• 04048266000668: TiAl6V4 ELI non-sterile
• 04048266000651: TiAl6V4 ELI non-sterile
• 04048266000644: TiAl6V4 ELI non-sterile
• 04048266000637: TiAl6V4 ELI non-sterile
• 04048266000620: TiAl6V4 ELI non-sterile
• 04048266000613: TiAl6V4 ELI non-sterile
• 04048266000606: TiAl6V4 ELI non-sterile
• 04048266000590: TiAl6V4 ELI non-sterile
• 04048266000583: TiAl6V4 ELI non-sterile
• 04048266000576: TiAl6V4 ELI non-sterile
• 04048266000569: TiAl6V4 ELI non-sterile
• 04048266000552: TiAl6V4 ELI non-sterile
• 04048266000545: TiAl6V4 ELI non-sterile
• 04048266000538: TiAl6V4 ELI non-sterile
• 04048266000521: TiAl6V4 ELI non-sterile
• 04048266000514: TiAl6V4 ELI non-sterile
• 04048266147684: TiAl6V4 ELI sterile
• 04048266147653: TiAl6V4 ELI sterile
• 04048266147646: TiAl6V4 ELI sterile
• 04048266147639: TiAl6V4 ELI sterile
• 04048266147622: TiAl6V4 ELI sterile
• 04048266147615: TiAl6V4 ELI sterile
• 04048266147608: TiAl6V4 ELI sterile
• 04048266147592: TiAl6V4 ELI sterile
• 04048266147585: TiAl6V4 ELI sterile
• 04048266147578: TiAl6V4 ELI sterile
• 04048266147561: TiAl6V4 ELI sterile
• 04048266147554: TiAl6V4 ELI sterile
• 04048266147547: TiAl6V4 ELI sterile
• 04048266147530: TiAl6V4 ELI sterile
• 04048266147523: TiAl6V4 ELI sterile
• 04048266147516: TiAl6V4 ELI sterile
• 04048266147486: TiAl6V4 ELI sterile
• 04048266147479: TiAl6V4 ELI sterile
• 04048266147462: TiAl6V4 ELI sterile
• 04048266147455: TiAl6V4 ELI sterile
• 04048266147417: TiAl6V4 ELI sterile
• 04048266147400: TiAl6V4 ELI sterile