AccessGUDID - DEVICE: the Wand Handpiece (20618874000107)

GUDID

Device Identifier (DI) Information

Brand Name: the Wand Handpiece
Version or Model: WA-2050A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Milestone Scientific Inc.

Primary DI Number: 20618874000107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 600
Labeler D-U-N-S® Number*: 006891188 *Terms of Use

Device Description: WA Handpiece without 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 [?]
K961648	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: c6524950-d71e-4cc1-ba40-3d404357ee78
Public Version Date: December 21, 2022
Public Version Number: 5
DI Record Publish Date: January 26, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00618874028015 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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