AMT Initial Placement Dilator Set IP-DIL-10

GUDID 00842071130602

AMT Initial Placement Dilator Set (10F)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy procedure kit Gastrostomy procedure kit Gastrostomy procedure kit Gastrostomy procedure kit
Primary Device ID00842071130602
NIH Device Record Key2c7b2ab6-e371-49b6-9cb1-b5be20ed5a14
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Initial Placement Dilator Set
Version Model NumberIP-DIL-10
Catalog NumberIP-DIL-10
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
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071130602 [Primary]
GS100842071130602 [Primary]
GS100842071130602 [Primary]
GS100842071130602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)
KNTTubes, Gastrointestinal (And Accessories)
KNTTubes, Gastrointestinal (And Accessories)
KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [AMT Initial Placement Dilator Set]

00842071106867AMT Initial Placement Dilator Set
00842071130602AMT Initial Placement Dilator Set (10F)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.