AMT Initial Placement Kit

GUDID 00842071106843

AMT Initial Placement Kit (12-18FR)

APPLIED MEDICAL TECHNOLOGY, INC.

Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use
Primary Device ID00842071106843
NIH Device Record Keyd69cd421-3a44-4d5c-a49e-8f9ec0cc338e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Initial Placement Kit
Version Model NumberIP-1218
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
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
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
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
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
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
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
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
Phone(440) 717-4000
Emailcs@appliedmedical.net

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Device Identifiers

Device Issuing AgencyDevice ID
GS100842071106843 [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 Number6
Public Version Date2020-02-06
Device Publish Date2016-08-31

On-Brand Devices [AMT Initial Placement Kit]

00842071106850AMT Initial Placement Kit with Sheaths (12-18FR)
00842071106843AMT Initial Placement Kit (12-18FR)
00842071131432AMT Initial Placement Kit with Sheaths (12-18FR)
00842071131425AMT Initial Placement Kit (12-18FR)

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