FDA.reportPublic FDA data

FENTEX

Primary DI
04250407705749
Brand
FENTEX
Company
FENTEX medical GmbH
Model
051702FX
Catalog number
051702FX
Device description
Tongue Depressor by Wieder 15 cm, blade width 35 mm, size 2
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
04250407705749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407705749042504077057494250407705749

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, surgicalA hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). 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
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00190776421366MillenniumAvalign Technologies, Inc.LRC2026-05-05
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09348811172143INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-03-18
08904461031080OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
08904461055697OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
00190776416218MillenniumAvalign Technologies, Inc.LRC2026-02-12