FDA.reportPublic FDA data

FENTEX

Primary DI
04250407786571
Brand
FENTEX
Company
FENTEX medical GmbH
Model
540770FX
Catalog number
540770FX
Device description
Smoke Evacuation Tube
Published
2024-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250407786571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407786571042504077865714250407786571

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00198506091896ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091902ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091971ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506093623ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
04059453127471Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04059453133809Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04250407785765FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785772FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785789FENTEXFENTEX medical GmbHLRC2022-12-15
04250407736866FENTEXFENTEX medical GmbHLRC2022-12-12
04250407736873FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737252FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737443FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737559FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737573FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737597FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737610FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737771FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737788FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737856FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738051FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738082FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738099FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738105FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738112FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738174FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738242FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738259FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738266FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738273FENTEXFENTEX medical GmbHLRC2022-12-12