FDA.report

DOVCC-1.6

Primary DI
00814005022680
Brand
DOVCC-1.6
Company
Quality Aspirators, Inc.
Model
DOVCC-1.6
Catalog number
310-10009
Device description
DOVCC-1.6
Published
2025-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00814005022680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00814005022680008140050226808140050226800814005022680

GMDN Terms

TermDefinition
Dental material injection cannula, reusableA 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 reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
121431159
Device count
1
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
true
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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0081400502026615P3HO15P3HO300-100272025-02-27
0081400502027315P3AT15P3AT300-100292025-02-27

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