Zeramex(R) Surgical Ratchet

GUDID 04063494000075

Josef Ganter Feinmechanik GmbH

Dental torque wrench

• Primary Device ID: 04063494000075
• NIH Device Record Key: 578d5d0b-0d1b-4dc4-a80e-1a6e20c99d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zeramex(R) Surgical Ratchet
• Version Model Number: P48935
• Company DUNS: 317178606
• Company Name: Josef Ganter Feinmechanik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04063494000075 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

[04063494000075]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-31
• Device Publish Date: 2021-03-23

Devices Manufactured by Josef Ganter Feinmechanik GmbH

• 04063494000075 - Zeramex(R) Surgical Ratchet: 2021-03-31
• 04063494000075 - Zeramex(R) Surgical Ratchet: 2021-03-31
• 04063494000082 - NobelPearlTM Manual Torque Wrench: 2021-03-31
• 04063494000099 - Zeramex(R) Ratchet Adaptor Unit Short: 2021-03-31
• 04063494000105 - NobelPearlTM Manual Torque Wrench Adapter: 2021-03-31