AccessGUDID - DEVICE: Walser® matrices (04262363910648)

GUDID

Device Identifier (DI) Information

Brand Name: Walser® matrices
Version or Model: 026Spez
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dr. Walser Dental GmbH

Primary DI Number: 04262363910648
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344549605 *Terms of Use

Device Description: Set of Special Walser® matrices with Walser® matrix forceps plus 1x # 10c, 1x # 6c, 1x # 24, 1x # 10a, 1x # 8a according to G. R. Daiger

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:	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?
35851	Rubber dam clamp forceps	A hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. This is a reusable device.	Active	false
16195	Dental matrix band, reusable	A band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

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: 08bc8e4b-144f-4774-b806-373bebba7fd1
Public Version Date: December 14, 2022
Public Version Number: 2
DI Record Publish Date: December 05, 2022