FDA.reportPublic FDA data

Endocraft LLC

Primary DI
00860009975170
Brand
Endocraft LLC
Company
Endocraft, LLC
Model
UMG105-SCN
Catalog number
UMG105-SCN
Device description
Single Lumen Suction Cannula for use in laser surgery to evacuate smoke plume.
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBRUnit, Suction Operatory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBRUnit, Suction OperatoryDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009975170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009975170008600099751708600099751700860009975170

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
401-369-7344info@endocraft-llc.com

Regulatory Flags#

DUNS number
039432148
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009975194Endocraft LLCUMG106-LCUMG106-LC2023-07-21
00860009975187Endocraft LLCUMG105-LCNUMG105-LCN2023-07-21
00860009975101Endocraft LLCSlimUMG100SlimUMG1002023-07-07
00860009975118Endocraft LLCHHA-EUROHHA-EURO2023-07-07
00860009975125Endocraft LLCIS77IS772023-07-07
00860009975132Endocraft LLCZVG100AZVG100A2023-07-07
00860009975149Endocraft LLCUMG100AUMG100A2023-07-06
00860009975156Endocraft LLCZIN-100AZIN-100A2023-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841709122286MidmarkMIDMARK CORPORATIONEBR2026-02-20
06971119541910Suction machineGuangdong JINME Medical Technology Co., Ltd.EBR2025-07-15
07898938244220MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
07898938244237MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
07898938244732MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
00810032660710Isolite, i2ZYRIS, INC.EBR2024-04-19
00810032660758Isolite, i2ZYRIS, INC.EBR2024-04-19
00810032660765Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660772Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660789Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660796Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660802Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660819Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660826Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660833Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660840Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660857Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660864Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660871Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660888Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660901Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660925Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660932Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660949Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660956Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660963Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660970IsovacZYRIS, INC.EBR2024-04-19
00810032660987Anterior MouthpieceZYRIS, INC.EBR2024-04-19
00810032661007Anterior Hose KitZYRIS, INC.EBR2024-04-19
00810032661014Operating Room AdapterZYRIS, INC.EBR2024-04-19