FDA.reportPublic FDA data

FENTEX

Primary DI
04250407710569
Brand
FENTEX
Company
FENTEX medical GmbH
Model
111108FX
Catalog number
111108FX
Device description
Suction Tube by Frazier with graduation, with cut-off hole WL 10 cm, 8 Fr.
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04250407710569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407710569042504077105694250407710569

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. 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
04250407748814FENTEX711160FX711160FX2022-12-12
04250407748821FENTEX711161FX711161FX2022-12-12
04250407748838FENTEX711162FX711162FX2022-12-12
04250407748845FENTEX711166FX711166FX2022-12-12
04250407748852FENTEX711167FX711167FX2022-12-12
04250407749231FENTEX716500FX716500FX2022-12-12
04250407749255FENTEX716516FX716516FX2022-12-12
04250407749262FENTEX716549FX716549FX2022-12-12
04250407749279FENTEX716600FX716600FX2022-12-12
04250407749286FENTEX716700FX716700FX2022-12-12
04250407749293FENTEX716702FX716702FX2022-12-12
04250407749309FENTEX716703FX716703FX2022-12-12
04250407749316FENTEX716704FX716704FX2022-12-12
04250407753283FENTEX811160FX811160FX2022-12-12
04250407753788FENTEX816500FX816500FX2022-12-12
04250407753801FENTEX816600FX816600FX2022-12-12
04250407753825FENTEX816700FX816700FX2022-12-12
04250407753832FENTEX816702FX816702FX2022-12-12
04250407753849FENTEX816703FX816703FX2022-12-12
04250407753856FENTEX816704FX816704FX2022-12-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08904461031073OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
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04059453133779Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-02-02
00198506088346ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-30
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09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
00190776415495MillenniumAvalign Technologies, Inc.LRC2026-01-27
00198506088070ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-23
00198506087813ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-16