AccessGUDID - DEVICE: PlastCare (D066PGNEEDLE27GS41)

GUDID

Device Identifier (DI) Information

Brand Name: PlastCare
Version or Model: PG-NEEDLE 27GS/4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PG-NEEDLE 27GS/4
Company Name: Proguard Health, Inc

Primary DI Number: D066PGNEEDLE27GS41
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 27G/SHORT, 0.4mm x 30mm (Yellow)

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: f6dfbc0d-3b06-4a90-ba0b-2bf1908b5043
Public Version Date: July 12, 2021
Public Version Number: 1
DI Record Publish Date: July 02, 2021