AccessGUDID - DEVICE: AMT Initial Placement Dilator Set (00842071140182)

GUDID

Device Identifier (DI) Information

Brand Name: AMT Initial Placement Dilator Set
Version or Model: IP-DIL-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IP-DIL-10
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071140182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: AMT Initial Placement Dilator Kit (10F), MDR

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64462	Gastrostomy procedure kit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, Gastrointestinal (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073034	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 Fr

Device Record Status

Public Device Record Key: 7ec1c373-e234-4f59-a50c-d3abcec868be
Public Version Date: September 02, 2024
Public Version Number: 1
DI Record Publish Date: August 23, 2024