FDA.reportPublic FDA data

FENTEX

Primary DI
04250407740825
Brand
FENTEX
Company
FENTEX medical GmbH
Model
530105FX
Catalog number
530105FX
Device description
Operating Laryngoscope for long neck 22 cm, a/b/c = 26/17/13 x 18 mm
Published
2022-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04250407740825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407740825042504077408254250407740825

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laryngopharyngoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle, or the device may allow for direct visualization through the lumen of its shaft/working channel. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4974679496212s.renner@fentexmedical.com

Regulatory Flags#

DUNS number
507221724
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
04250407736507FENTEX441918FX441918FX2022-12-12
04250407736514FENTEX441920FX441920FX2022-12-12
04250407736538FENTEX442014FX442014FX2022-12-12
04250407736545FENTEX442018FX442018FX2022-12-12
04250407736552FENTEX442020FX442020FX2022-12-12
04250407736576FENTEX442114FX442114FX2022-12-12
04250407736590FENTEX442118FX442118FX2022-12-12
04250407736606FENTEX442120FX442120FX2022-12-12
04250407736637FENTEX442214FX442214FX2022-12-12
04250407736644FENTEX442218FX442218FX2022-12-12
04250407736651FENTEX442220FX442220FX2022-12-12
04250407736675FENTEX442314FX442314FX2022-12-12
04250407736682FENTEX442318FX442318FX2022-12-12
04250407736699FENTEX442320FX442320FX2022-12-12
04250407736712FENTEX442414FX442414FX2022-12-12
04250407736729FENTEX442418FX442418FX2022-12-12
04250407736736FENTEX442420FX442420FX2022-12-12
04250407736750FENTEX442514FX442514FX2022-12-12
04250407736767FENTEX442518FX442518FX2022-12-12
04250407736774FENTEX442520FX442520FX2022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957506Create BiotechCREATE BIOTECH CO., LTD.CCW2026-07-21
10884521859999McGRATH MAC+Covidien LPCCW2026-07-03
04053755200122visionPRO Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-24
04053755213092MEDUVISION Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213108MEDUVISION Mac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213115MEDUVISION Mac 2 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213122MEDUVISION Mac 4 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
00842209139149NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139156NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139163NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139170NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139187NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139194NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139200NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00810055257607Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257614Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257621Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257638Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257645Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257652Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257669Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257676Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257683Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257690Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257706Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257713Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257720Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257737Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09