4 INCH LOGO PERF NYLON FILM (0024) 01I0024

GUDID 00303620000208

4 INCH LOGO PERF NYLON FILM (0024)

SEPTODONT, INC

Sterilization packaging, single-use
Primary Device ID00303620000208
NIH Device Record Key14a38524-7ae0-443e-b51a-5031e9b3155d
Commercial Distribution StatusIn Commercial Distribution
Brand Name4 INCH LOGO PERF NYLON FILM (0024)
Version Model Number01I0024
Catalog Number01I0024
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

Width4 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100303620000208 [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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00303620000109 - 2 INCH CLEAR CONT NYL FILM (0002)2019-11-08 2 INCH CLEAR CONT NYL FILM (0002)
00303620000116 - 3 INCH CLEAR CONT NYLON FILM (0003)2019-11-08 3 INCH CLEAR CONT NYLON FILM (0003)

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