AccessGUDID - DEVICE: PlastCare (D066PGNEEDLE30GS41)

GUDID

Device Identifier (DI) Information

Brand Name: PlastCare
Version or Model: PG-NEEDLE 30GS/4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PG-NEEDLE 30GS/4
Company Name: Proguard Health, Inc

Primary DI Number: D066PGNEEDLE30GS41
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 129529337 *Terms of Use

Device Description: Anesthetic Dental Needles 30G/Short, 0.3mm x 21 mm (Blue)

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
63975	Dental anaesthesia syringe, single-use	A hand-held, manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle (needle not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZM	Needle, Dental

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: ffb9d06f-f7cf-4168-9a3b-e773cbb4fe41
Public Version Date: July 12, 2021
Public Version Number: 1
DI Record Publish Date: July 02, 2021