AccessGUDID - DEVICE: PLASTIC PIPETTES 1mL

GUDID

Device Identifier (DI) Information

Brand Name: PLASTIC PIPETTES 1mL - 5 pieces
Version or Model: 11752
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Produits dentaires S.A.

Primary DI Number: 07640159161578
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480420090 *Terms of Use

Device Description: PLASTIC PIPETTES 1mL - 5 pieces One assortment of 5 color-coded pipette For introducing solutions into the root canal or cavities

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:	Yes
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?
35970	Dental irrigation/aspiration syringe	A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIC	Syringe, Periodontic, Endodontic, Irrigating

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: 57a43fbf-c42a-4d1f-9d7b-ed0d78f1266c
Public Version Date: June 23, 2022
Public Version Number: 1
DI Record Publish Date: June 15, 2022