FDA.report

Pre-Bent Flow Tips

Primary DI
00616784221236
Brand
Pre-Bent Flow Tips
Company
DYNAREX CORPORATION
Model
2212
Device description
Pre-Bent Flow Tips, 20G, Flow-Sealant Tips, Black
Published
2021-06-21
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
00616784221236PackageGS125In Commercial Distribution
00616784221212PrimaryGS10
00616784221205Unit of UseGS10
00810180843409Unit of UseGS10

GMDN Terms

TermDefinition
Dental anaesthesia syringe/needleA 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 included sterile needle; the needle may be attached or detached. The syringe is typically made of plastic and/or silicone materials. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true
Sterilization required before use
false

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