ProShape Gutta Percha ISO 45.04

GUDID 10810138822965

Endo Direct LLC

Synthetic gutta-percha

• Primary Device ID: 10810138822965
• NIH Device Record Key: 9366200a-6690-49f2-bd80-3a11eb50989c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProShape Gutta Percha ISO 45.04
• Version Model Number: PSGP4504
• 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	10810138822965 [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: 2024-08-12
• Device Publish Date: 2024-08-02

On-Brand Devices [ProShape Gutta Percha ISO 45.04]

• 10810138822385: SDPP5504
• 10810138822965: PSGP4504