AccessGUDID - DEVICE: Qlicksmart SnapIT Regular Blue (09337363001742)

GUDID

Device Identifier (DI) Information

Brand Name: Qlicksmart SnapIT Regular Blue
Version or Model: SN-01Rb
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SN-01Rb-Em Blue
Company Name: QLICKSMART PTY LTD

Primary DI Number: 09337363001742
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 755003498 *Terms of Use

Device Description: Qlicksmart’s SnapIT ampule openers are designed to protect you from cuts when opening a glass ampule.

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):	No
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?
10098	Ampule opener	A cutting instrument intended to safely remove/break the protective, sterile seal of an ampule. It is typically designed to protect the user from inadvertent contact with the sharp edges of the seal while being removed. This is a reusable device.	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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 0fc94f5f-5c0e-4bd3-b3ef-7ccf98fb621f
Public Version Date: January 10, 2023
Public Version Number: 2
DI Record Publish Date: March 05, 2020