Capsule Dome G-Tube 9-C2420-I

GUDID 00842071133696

24FR Capsule Dome G-Tube (Enfit), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy tube
Primary Device ID00842071133696
NIH Device Record Keyc90bf2a3-af59-43c9-afd9-a7129be7e5ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapsule Dome G-Tube
Version Model Number9-C2420-I
Catalog Number9-C2420-I
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Device Dimensions

Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French
Catheter Gauge24 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071133696 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-26
Device Publish Date2024-08-16

On-Brand Devices [Capsule Dome G-Tube]

0084207113381824FR Capsule Dome G-Tube with Guidewire (Enfit), MDR
0084207113380124FR Capsule Dome G-Tube with Guidewire, MDR
0084207113379520FR Capsule Dome G-Tube with Guidewire (Enfit), MDR
0084207113378820FR Capsule Dome G-Tube with Guidewire, MDR
0084207113369624FR Capsule Dome G-Tube (Enfit), MDR
0084207113368924FR Capsule Dome G-Tube, MDR
0084207113367220FR Capsule Dome G-Tube (Enfit), MDR
0084207113366520FR Capsule Dome G-Tube, MDR

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