FDA.reportPublic FDA data

Endocraft LLC

Primary DI
00860009975132
Brand
Endocraft LLC
Company
Endocraft, LLC
Model
ZVG100A
Catalog number
ZVG100A
Device description
Zeitels Suspension Gallows positions and holds the laryngoscope and patient in ideal posture for surgery. This suspension mounts to the surgical bed, rather than on the patient's chest.
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
00860009975132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009975132008600099751328600099751320860009975132

GMDN Terms#

Term, Definition table
TermDefinition
Rigid laryngoscope positionerA noninvasive device designed to externally hold and position a rigid laryngoscope on the chest of a patient during an examination or intervention. It consists of a sturdy rod, a laryngoscope connector at one end, and a rubber base at the other end for placement on the patient’s chest to provide support and facilitate alignment of the laryngoscope relative to the patient’s body. This is a reusable device.

Sterilization Methods#

Method table
Method

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

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
00860009975125Endocraft LLCIS77IS772023-07-07
00860009975149Endocraft LLCUMG100AUMG100A2023-07-06
00860009975156Endocraft LLCZIN-100AZIN-100A2023-07-06

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08436031035018AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035216AirtraqPRODOL MEDITEC, SACCW2023-08-01
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