ProShape Gutta Percha ISO 35.04

GUDID 10810138822361

Endo Direct LLC

Synthetic gutta-percha

• Primary Device ID: 10810138822361
• NIH Device Record Key: a7afa9b9-90cd-467d-86c9-95f2be3f848f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProShape Gutta Percha ISO 35.04
• Version Model Number: SDPP4504
• 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	10810138822361 [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 Gutta Percha ISO 35.04]

• 10810138822361: SDPP4504
• 10810138822941: PSGP3504