6 INCH SELF SEAL POUCH (0036)

GUDID 00303620000253

6 INCH SELF SEAL POUCH (0036)

SEPTODONT, INC

Sterilization packaging, single-use
Primary Device ID00303620000253
NIH Device Record Key7a1e55ab-40b3-4e58-bd97-55eed2192f86
Commercial Distribution StatusIn Commercial Distribution
Brand Name6 INCH SELF SEAL POUCH (0036)
Version Model Number01I0036
Company DUNS012925513
Company NameSEPTODONT, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com

Device Dimensions

Width6 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100303620000253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRGWrap, Sterilization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-12

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