AMT Initial Placement Dilator Set

GUDID 00842071106867

AMT Initial Placement Dilator Set

APPLIED MEDICAL TECHNOLOGY, INC.

General-purpose non-vascular guidewire
Primary Device ID00842071106867
NIH Device Record Keyab234d40-9eeb-49b7-9367-c4e785e136d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Initial Placement Dilator Set
Version Model NumberIP-DIL
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(440) 717-4000
Emailcs@appliedmedical.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071106867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [AMT Initial Placement Dilator Set]

00842071106867AMT Initial Placement Dilator Set
00842071130602AMT Initial Placement Dilator Set (10F)
00842071131876AMT Initial Placement Dilator Kit (Smaller Dia GW)

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