DEXcam4™ Intra-oral Camera Sheaths 1.011.4989

GUDID 20618125155877

Custom fit for: DEXcam4 and DEXcam4HD Re-Order DEXIS Part Number 1.011.4989

TIDI PRODUCTS, LLC

Medical equipment drape, single-use
Primary Device ID20618125155877
NIH Device Record Keycd8eaa99-f7eb-4563-9ec4-4e08eb0792b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEXcam4™ Intra-oral Camera Sheaths
Version Model Number21025
Catalog Number1.011.4989
Company DUNS063519193
Company NameTIDI PRODUCTS, LLC
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100618125155873 [Unit of Use]
GS110618125155870 [Primary]
GS120618125155877 [Package]
Contains: 10618125155870
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

KQMCamera, Surgical And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-21
Device Publish Date2023-04-13

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