FDA.reportPublic FDA data

Endocraft LLC

Primary DI
00860009975118
Brand
Endocraft LLC
Company
Endocraft, LLC
Model
HHA-EURO
Catalog number
HHA-EURO
Device description
European Angled Horizontal Handle Assembly for use with Storz-stlye scopes to connect to Suspension Gallows
Published
2023-07-07
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
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009975118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009975118008600099751188600099751180860009975118

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, reusableThe hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. 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
00860009975170Endocraft LLCUMG105-SCNUMG105-SCN2023-07-21
00860009975187Endocraft LLCUMG105-LCNUMG105-LCN2023-07-21
00860009975101Endocraft LLCSlimUMG100SlimUMG1002023-07-07
00860009975125Endocraft LLCIS77IS772023-07-07
00860009975132Endocraft LLCZVG100AZVG100A2023-07-07
00860009975149Endocraft LLCUMG100AUMG100A2023-07-06
00860009975156Endocraft LLCZIN-100AZIN-100A2023-07-06

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