SAFE DENT

Primary DI
00854014003584
Brand
SAFE DENT
Company
BGSS Company Inc.
Model
A90126MC
Device description
A90126MC Air Water Syringe Tip "MULTI COLOR" (250) bag
Published
2024-05-01
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
ECBUnit, Syringe, Air And/Or Water

Product Code Classifications

CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00854014003584PackageGS140In Commercial Distribution
00854014003577PrimaryGS10
00854014003560Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854014003584008540140035848540140035840854014003584
00854014003577008540140035778540140035770854014003577
00854014003560008540140035608540140035600854014003560

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

Regulatory Flags

DUNS number
828474952
Device count
250
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00810339031831SAFE DENTLAB201M-BL2024-05-15
00810339031862SAFE DENTLAB202L-BL2024-05-15
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00854014003034SAFE DENTSTP-7001-A2024-05-15
00854014003065SAFE DENTSTP-7002-B2024-05-15
00854014003096SAFE DENTSTP-7003-C2024-05-15
00854014003126SAFE DENTSTP-7004-D2024-05-15
00854014003157SAFE DENTSTP-7004-E2024-05-15
00854014003188SAFE DENTSTP-7006-F2024-05-15
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00854014003683SAFE DENTPT8113BL2024-05-15
00854014003720SAFE DENTPT8114DR2024-05-15
00854014003751SAFE DENTPT8115LV2024-05-15
00854014003812SAFE DENTPT8117MG2024-05-15
00810339030018SAFE DENTP50132024-05-01

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D248B1619B0DurationHAGER WORLDWIDE, INC.ECB2024-05-20
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