FDA.report

Vista Metal Syringe tip

Primary DI
00818207024329
Brand
Vista Metal Syringe tip
Company
Vista Dental
Model
315385
Published
2022-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ECBUnit, Syringe, Air And/Or Water

Product Code Classifications

CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818207024329Direct MarkingGS10
10818207024326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818207024329008182070243298182070243290818207024329
1081820702432610818207024326

GMDN Terms

TermDefinition
Dental delivery system irrigation handpieceA hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
2626369755info@vista-dental.com

Regulatory Flags

DUNS number
036623932
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10818207024845Vista MST Visco Tip SS 22mm 50/cup3124122023-10-02
10818207024852Vista MST Visco Tip SS 17mm 20/cup3124132023-10-02
10818207024869Vista MST Visco Tip SS 22mm 20/cup3124142023-10-02
10818207024333VacuSeal Syringe3713A2023-06-09
10818207024340SmearOFF System (PS System)3730A2023-06-09
10818207024357PS System - Chlor-Xtra Plus Bag (40mL)803803-162023-06-09
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00850048528864Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
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20810021435958DCIDCI International, LLCECB2024-05-24
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