AMT PEG-Assist IP-10-S

GUDID 00842071130596

AMT PEG-Assist Initial Placement Kit (10F)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy procedure kit Gastrostomy procedure kit Gastrostomy procedure kit Gastrostomy procedure kit
Primary Device ID00842071130596
NIH Device Record Key230fe552-bb43-4302-b5f1-924c50860697
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT PEG-Assist
Version Model NumberIP-10-S
Catalog NumberIP-10-S
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
GS100842071130596 [Primary]
GS100842071130596 [Primary]
GS100842071130596 [Primary]
GS100842071130596 [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

Devices Manufactured by APPLIED MEDICAL TECHNOLOGY, INC.

00842071130596 - AMT PEG-Assist2020-11-10AMT PEG-Assist Initial Placement Kit (10F)
00842071130596 - AMT PEG-Assist2020-11-10 AMT PEG-Assist Initial Placement Kit (10F)
00842071130602 - AMT Initial Placement Dilator Set2020-11-10 AMT Initial Placement Dilator Set (10F)
00842071130626 - AMT Stiffener for Initial Placement2020-08-24 Guidewire Compatible Stiffener for Initial Placement, 10F Compatible (Pouched)
00842071129316 - Explant Express2020-05-06 Explant Express™ - Specimen Trap for Breast Implant Removal
00842071106843 - AMT Initial Placement Kit2020-02-06 AMT Initial Placement Kit (12-18FR)
00842071106850 - AMT Initial Placement Kit2020-02-06 AMT Initial Placement Kit with Sheaths (12-18FR)
00842071106690 - Y-Port Feeding Adapter2019-12-23 12 FR Y-Port Feeding Adapter (ISO SAF - Pouched)
00842071106706 - Y-Port Feeding Adapter2019-12-23 14 FR Y-Port Replacement (ISOSAF, Pouched)

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