FDA.report

Fluid Adaptor

Primary DI
07290112447692
Brand
Fluid Adaptor
Company
ETGAR - MEDICAL INSTRUMENTS LTD
Model
200-300-M2.5
Device description
DIVA - Fluid Adaptor
Published
2018-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290112447692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290112447692072901124476927290112447692

GMDN Terms

TermDefinition
Dental implant/syringe connectorA non-sterile device designed to facilitate the connection between a dental implant and a manual syringe during a dental restorative procedure (e.g., dispensing of saline or bone matrix material). This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
514570324
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
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07290112447340Measure Drill DepthETE-30402018-03-04
07290112447364Parallel guide for safety drillingET-30332018-03-04
07290112447371Guide PinET-01022018-03-04
07290112447388Guide PinET-01322018-03-04
07290112447418Depth ProbeET-00092018-03-04
07290112447593Gingiva Depth Guide ETS-30402018-03-04
07290112442635AbutmentEI-62092018-02-27
07290112442642AbutmentEI-62132018-02-27
07290112442659AbutmentEI-64112018-02-27
07290112442666AbutmentEI-60012018-02-27
07290112442673AbutmentEI-60022018-02-27
07290112442680AbutmentEI-60032018-02-27
07290112442697AbutmentEI-60042018-02-27
07290112442703AbutmentEI-63012018-02-27
07290112442710AbutmentEI-63022018-02-27
07290112442727AbutmentEI-63032018-02-27
07290112442734AbutmentEI-63042018-02-27
07290112442949AbutmentEAI-60412018-02-27
07290112442956AbutmentEAI-60422018-02-27
07290112442963AbutmentEAI-60432018-02-27

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Primary DIBrandCompanyProduct codePublished
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08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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