Soan

Primary DI
03760349809951
Brand
Soan
Company
DENTALHITEC
Model
SOAN1
Catalog number
SOAN1
Device description
1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521)
Published
2023-08-22
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

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760349809951Direct MarkingGS10
03760349805335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760349809951037603498099513760349809951
03760349805335037603498053353760349805335

GMDN Terms#

Term, Definition table
TermDefinition
Dental computer assisted anaesthesia injection unitA mains electricity (AC-powered) dental device intended to accurately administer a local anaesthetic agent within the oral cavity for improved analgesic localization and pain reduction. It is typically a bench-top unit with processing software, displays, and controls (e.g., foot-switch) intended to be used in conjunction with a dental anaesthesia cartridge, handpiece, and needle to form a complete computer assisted local anaesthetic delivery system. It is designed to measure and display fluid pressure variations at the needle tip to indicate needle location and aid anaesthetic agent injection; it may also measure fluid volumes and flow rates.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
640616736
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760349801054QUICKSLEEPER 5C_A2 US/CAQS_5C_A2QS_5C_A22025-12-22
03760349803331SleeperOne 5SO_5CSO-5C2023-08-22
03760349805335SoanSOAN1SOAN12023-08-22
03760349800507EFFITEC NEEDLE 30G EXTRA SHORTC3022C30222023-08-22
03760349800514EFFITEC NEEDLE 27G SHORTC3029C30292023-08-22
03760349800521EFFITEC NEEDLE 30G SHORTC3025C30252023-08-22
03760349809913SleeperOne 5SO_5CSO-5C2023-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D1250812Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250822Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10012Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10022Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10072Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10122Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D832BLT1011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3021PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4181PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4201PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4211PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4271PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT522B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT523B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT525B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT6301PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT630M1PlasdentPLASDENT CORPORATIONDZM2026-05-01
20192253037422MonojectCardinal Health 200, LLCDZM2026-04-02