AccessGUDID - DEVICE: the Wand STA Handpiece (20618874000039)

GUDID

Device Identifier (DI) Information

Brand Name: the Wand STA Handpiece
Version or Model: STA-5050-2725
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Milestone Scientific Inc.

Primary DI Number: 20618874000039
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 600
Labeler D-U-N-S® Number*: 006891188 *Terms of Use

Device Description: STA Handpiece with needle

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?
60601	Dental computer assisted anaesthesia injection handpiece	A sterile, hand-held component of a dental computer assisted local anaesthesia delivery system intended to accurately administer a local anaesthetic agent within the oral cavity for improved analgesic localization and pain reduction. It is typically designed in the form of a pen or wand connected to a dental computer assisted anaesthesia injection unit via tubing, and used in conjunction with a dental anaesthesia cartridge and a needle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJI	Syringe, Cartridge

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061904	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 35284dbf-ad06-4fdf-8d77-212d109b1a96
Public Version Date: December 21, 2022
Public Version Number: 5
DI Record Publish Date: January 26, 2018