AccessGUDID - DEVICE: CONTA-GUARD (05713513000362)

GUDID

Device Identifier (DI) Information

Brand Name: CONTA-GUARD
Version or Model: 2222
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rønvig Dental Manufacturing A/S

Primary DI Number: 05713513000362
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 307549241 *Terms of Use

Device Description: A autoclavable Recapping Stand for one-handed handling of injection needles to avoid needle stick injuries.

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):	Yes
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?
37461	Needle recapping device, reusable	A device intended to hold a needle cap and allow a user to conveniently recap a needle, providing some user protection against needle sticks. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BRW	Protector, Dental

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

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: e6947bb9-330c-4554-ade9-61a9f86f9a69
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022