AccessGUDID - DEVICE: NA (10888551001076)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MED15-105
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MED15-105
Company Name: STERILMED, INC.

Primary DI Number: 10888551001076
Issuing Agency: GS1
Commercial Distribution End Date: December 13, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 175899459 *Terms of Use

Device Description: BALLOON INFLATION DEVICE ENCORE 26

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
46633	Catheter/overtube balloon inflator, reprocessed	A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKU	INJECTOR AND SYRINGE, ANGIOGRAPHIC, BALLOON INFLATION, REPROCESSED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ffad0fc-9cd5-4d0e-9a61-c2639872954a
Public Version Date: January 10, 2025
Public Version Number: 7
DI Record Publish Date: September 22, 2016