FDA.reportPublic FDA data

Endocraft LLC

Primary DI
00860009975125
Brand
Endocraft LLC
Company
Endocraft, LLC
Model
IS77
Catalog number
IS77
Device description
Zeitels Intubation Scope. Slotted speculum to pass tube through trachea with Fiber optic carrier. Modular handle.
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
00860009975125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009975125008600099751258600099751250860009975125

GMDN Terms#

Term, Definition table
TermDefinition
Rigid intubation laryngoscope, reusableA hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can 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
00860009975118Endocraft LLCHHA-EUROHHA-EURO2023-07-07
00860009975132Endocraft LLCZVG100AZVG100A2023-07-07
00860009975149Endocraft LLCUMG100AUMG100A2023-07-06
00860009975156Endocraft LLCZIN-100AZIN-100A2023-07-06

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