AMT Stiffener for Initial Placement E4-6200, 4-6200

GUDID 00842071148966

Guidewire Compatible Stiffener for Initial Placement (Longer Length, Pouched), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Peritoneal catheter stylet
Primary Device ID00842071148966
NIH Device Record Key4b68066e-65b2-4221-bd23-615482cae7a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT Stiffener for Initial Placement
Version Model NumberE4-6200
Catalog NumberE4-6200, 4-6200
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071148959 [Primary]
GS100842071148966 [Package]
Contains: 00842071148959
Package: Box (4-6200) [10 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-26
Device Publish Date2025-08-18

On-Brand Devices [AMT Stiffener for Initial Placement]

00842071111809Guidewire Compatible Stiffener for Initial Placement (Pouched)
00842071130626Guidewire Compatible Stiffener for Initial Placement, 10F Compatible (Pouched)
00842071131173Introducer / Stiffener for Initial Placement (Long Length, Pouched)
00842071148966Guidewire Compatible Stiffener for Initial Placement (Longer Length, Pouched), MDR
00842071136376Guidewire Compatible Stiffener for Initial Placement (Pouched), MDR

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