AccessGUDID - DEVICE: MAP SYSTEM, MAP One (1 needle-kit) (07640159160335)

GUDID

Device Identifier (DI) Information

Brand Name: MAP SYSTEM, MAP One (1 needle-kit)
Version or Model: 20296
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Produits dentaires S.A.

Primary DI Number: 07640159160335
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480420090 *Terms of Use

Device Description: 1 Stainless steel syringe 1 Niti Memory shape Needle N°1 Red 8 spare POM plungers N°1 Red 1 Niti cleaning curette N°1 Red

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?
35696	Dental amalgam carrier	A hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKI	Carrier, Amalgam, Operative

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: 0dd8dfcb-1575-4db0-bd98-2af60df2f45b
Public Version Date: June 29, 2022
Public Version Number: 1
DI Record Publish Date: June 21, 2022