FDA.reportPublic FDA data

AMT PEG-Assist

Primary DI
00842071130596
Brand
AMT PEG-Assist
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
IP-10-S
Catalog number
IP-10-S
Device description
AMT PEG-Assist Initial Placement Kit (10F)
Published
2020-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073034000AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)Applied Medical Technology, Inc.2008-03-14KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071130596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071130596008420711305968420711305960842071130596

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy procedure kitA collection of surgical devices, which does not include a gastrostomy tube, intended to assist with a gastrostomy procedure (the surgical creation of a stoma into the stomach for placement of a gastrostomy tube). It typically includes devices dedicated to tube introduction/function (e.g., introduction needle, guidewire, dilator, fastener) with a surgical cutting device(s) intended to be used to perform the gastrostomy (e.g., scalpel). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(440) 717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071145774MINI Balloon Button5-12105-12102026-10-09
00842071145781MINI Balloon Button5-1210-I5-1210-I2026-10-09
00842071146573MINI Balloon Button5-18105-18102026-10-09
00842071146580MINI Balloon Button5-1810-I5-1810-I2026-10-09
00842071146610MINI Balloon Button5-18155-18152026-10-09
00842071146627MINI Balloon Button5-1815-I5-1815-I2026-10-09
00842071146658MINI Balloon Button5-18205-18202026-10-09
00842071146665MINI Balloon Button5-1820-I5-1820-I2026-10-09
00842071146290MINI Balloon Button5-14605-14602026-09-29
00842071146306MINI Balloon Button5-1460-I5-1460-I2026-09-29
00842071146313MINI Balloon Button5-14655-14652026-09-29
00842071146320MINI Balloon Button5-1465-I5-1465-I2026-09-29
00842071146351MINI Balloon Button5-16125-16122026-09-29
00842071146368MINI Balloon Button5-1612-I5-1612-I2026-09-29
00842071146399MINI Balloon Button5-16175-16172026-09-29
00842071146405MINI Balloon Button5-1617-I5-1617-I2026-09-29
00842071146450MINI Balloon Button5-16255-16252026-09-29
00842071146467MINI Balloon Button5-1625-I5-1625-I2026-09-29
00842071146511MINI Balloon Button5-16355-16352026-09-29
00842071146528MINI Balloon Button5-1635-I5-1635-I2026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816340021663ND60EL-HFNEODEVICES INCKNT2026-10-13
00842071145774MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071145781MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146573MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146580MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146610MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146627MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146658MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146665MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00350770005881CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00350770007915CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00842071146290MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146306MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146313MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146320MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146351MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146368MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146399MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146405MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146450MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146467MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146511MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146528MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146559MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146566MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146597MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146603MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21