FDA.reportPublic FDA data

Endocraft LLC

Primary DI
00860009975101
Brand
Endocraft LLC
Company
Endocraft, LLC
Model
SlimUMG100
Catalog number
SlimUMG100
Device description
Zeitels Slim Universal Modular Glottiscope System is a Modular Laryngoscope for Vocal surgery. This product contains 3 blades of different sizes and one handle. Also included is a suction Cannula, a light carrier, and a fiberoptic light cable. It is slimmer and designed geometrically to enhance access to tighter surgical sites.
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
00860009975101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009975101008600099751018600099751010860009975101

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
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
15056094505435PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
15056094505480PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
15056094505497PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505319PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505326PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505333PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505340PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505357PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505364PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505371PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505395PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505401PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505418PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505425PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505456PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505463PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505470PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
00190776434038MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434045MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434052MillenniumAvalign Technologies, Inc.CCW2026-10-09
06971834830016Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830023Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830030Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830047Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830542Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830559Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830566Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830573Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830580Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830597Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30