3 INCH SELF SEAL POUCH (0033)

GUDID 00303620000239

3 INCH SELF SEAL POUCH (0033)

SEPTODONT, INC

Sterilization packaging, single-use

• Primary Device ID: 00303620000239
• NIH Device Record Key: 7d1825d3-e883-49a0-9300-c8c985fa2a2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 INCH SELF SEAL POUCH (0033)
• Version Model Number: 01I0033
• Company DUNS: 012925513
• Company Name: SEPTODONT, INC
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com

Device Dimensions

• Width: 3 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303620000239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870147

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-12

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