FDA.report

Pressure Syringe Needles

Primary DI
D701PSN18A2
Brand
Pressure Syringe Needles
Company
PULPDENT CORPORATION
Model
PSN-18A
Device description
18 gauge x 1 1/4", green. Package of 30
Published
2021-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZMNeedle, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D701PSN18A2PrimaryHIBCC0
D701PSN18A1Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001006089
Device count
30
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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