ProShape One Gutta Percha Primary

GUDID 10810138822262

Endo Direct LLC

Synthetic gutta-percha

• Primary Device ID: 10810138822262
• NIH Device Record Key: 7aed1afa-3908-4fd6-8d59-ac50b5e62156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProShape One Gutta Percha Primary
• Version Model Number: SDGP30061
• Company DUNS: 125216703
• Company Name: Endo Direct LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	10810138822262 [Primary]

FDA Product Code

• EKM: Gutta-Percha

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-15

On-Brand Devices [ProShape One Gutta Percha Primary]

• 10810138822262: SDGP30061
• 10810138822842: PSOGPPR