FDA.reportPublic FDA data

AMT Introducer

Primary DI
00842071111793
Brand
AMT Introducer
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E4-5000
Catalog number
E4-5000, 4-5000
Device description
Introducer (Pouched)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K042300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042300000AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEMApplied Medical Technology, Inc.2004-10-25KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071111793PackageGS110In Commercial Distribution
00842071106881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071111793008420711117938420711117930842071111793
00842071106881008420711068818420711068810842071106881

GMDN Terms#

Term, Definition table
TermDefinition
Catheter styletA metal wire or flexible rod, typically with a plastic knob at the proximal end, that is inserted into the lumen of a catheter or cannula to provide internal reinforcement to increase the stiffness enough to facilitate manipulation and introduction into the body for various procedures. It is available in various lengths, diameters, and degrees of rigidity. Some types can include small passive magnets that generate a magnetic field which is detectable by an external catheter stylet magnet detector. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
038101861
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071153144AMT MiniONE Extension SetE8-2455-ISOSAFE8-2455-ISOSAF, 8-2455-ISOSAF2026-05-13
00842071147198MINI Balloon Button5-24272026-05-07
00842071147204MINI Balloon Button5-2427-I5-2427-I2026-05-07
00842071153045AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-04-28
00842071153069AMT MiniSPC Drainage SetES1-2421ES1-2421, S1-24212026-04-28
00842071146276MINI Balloon Button5-14555-14552026-04-09
00842071146283MINI Balloon Button5-1455-I5-1455-I2026-04-09
00842071148935GEMINI Suture LoopES4-8000ES4-8000, S4-80002025-04-07
00842071151119RHAPSOESD110-S-07ESD110-S-07, SD110-S-07-101, SD110-S-07-1052026-03-25
00842071151140RHAPSOESD110-C-07ESD110-C-07, SD110-C-07-101, SD110-C-07-1052026-03-25
00842071153021AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071153038AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071150952AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-03-18
00842071150976AMT MiniSPC Drainage SetES1-2421ES1-2421, S1-24212026-03-18
00842071152758MiniSPC ButtonSPC-2425-12SPC-2425-122026-03-18
00842071152765MiniSPC ButtonSPC-2425-24SPC-2425-242026-03-18
00842071152772MiniSPC ButtonSPC-2427-12SPC-2427-122026-03-18
00842071152789MiniSPC ButtonSPC-2427-24SPC-2427-242026-03-18
00842071152796MiniSPC ButtonSPC-2430-12SPC-2430-122026-03-18
00842071152802MiniSPC ButtonSPC-2430-24SPC-2430-242026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253011210KangarooCardinal Health 200, LLCKNT2026-04-17
10192253006834Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006841Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011616CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
10192253011128KangarooCardinal Health 200, LLCKNT2025-05-28
10192253011159CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011197CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011227CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011258CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011272CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011296CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011630CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
10192253011319KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011333KangarooCardinal Health 200, LLCKNT2024-06-13