AccessGUDID - DEVICE: SPREADER A (J003A0198030000001)

GUDID

Device Identifier (DI) Information

Brand Name: SPREADER A
Version or Model: A019803000000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A019803000000
Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl

Primary DI Number: J003A0198030000001
Issuing Agency: HIBCC
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 480538495 *Terms of Use

Device Description: N/A

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?
37678	Manual endodontic filling material spreader	A hand-held, manually-operated dental instrument specifically designed to compress filling materials in a root canal, mainly in a lateral direction. The working part is tapered, circular in cross-section and has a pointed tip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKK	SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

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
Special Storage Condition, Specify: N/A

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6fa35096-0e70-41c4-aad5-4143c1bf6fd8
Public Version Date: January 24, 2024
Public Version Number: 2
DI Record Publish Date: September 30, 2022