AccessGUDID - DEVICE: SONTEC UNIVERSAL BOTTLE OPENER (00192896091023)

GUDID

Device Identifier (DI) Information

Brand Name: SONTEC UNIVERSAL BOTTLE OPENER
Version or Model: 1103-620
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1103-620
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896091023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: SONTEC UNIVERSAL BOTTLE OPENER

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:	No
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?
30093	Container opening aid	A device designed to be used by a person with a disability for the purpose of opening vessels that typically contain food or drink, e.g., cans, bottles, containers. Included are support plates for some opener designs.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 7.5 Inch

Device Record Status

Public Device Record Key: e6933031-1848-46c7-b1df-2b0b8436f5c7
Public Version Date: December 24, 2018
Public Version Number: 1
DI Record Publish Date: November 22, 2018