AccessGUDID - DEVICE: Non-Balloon Removal Tool (00842071132132)

GUDID

Device Identifier (DI) Information

Brand Name: Non-Balloon Removal Tool
Version or Model: R-L3033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R-L3033
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071132132
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: 18-24F x 3.0-3.3cm Non-Balloon Removal Tool (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?
38565	Gastrostomy button	A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170319	000
K980305	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: 18-24F
Device Size Text, specify: 3.0-3.3 cm

Device Record Status

Public Device Record Key: d450cb48-7d1e-46d1-80c3-de5f0bc0e25f
Public Version Date: September 10, 2024
Public Version Number: 2
DI Record Publish Date: June 14, 2024