FDA.reportPublic FDA data

FENTEX

Primary DI
04250407736200
Brand
FENTEX
Company
FENTEX medical GmbH
Model
440702FX
Catalog number
440702FX
Device description
Adenotome by Shambough detachable 23 cm, size 2
Published
2022-12-12
Public version status
Update
Distribution status
Not 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
04250407736200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407736200042504077362004250407736200

GMDN Terms#

Term, Definition table
TermDefinition
AdenotomeA hand-held manual surgical instrument designed to excise hypertrophic lymphoid tissue in the nasopharynx (i.e., pharyngeal tonsils or adenoids) during a procedure known as an adenoidectomy. It is typically a long, slender instrument with cutting blades at the working end, and a handle with a mechanism to operate the blades. It is available in various designs and sizes and may be a one-piece instrument or require the insertion of the blades into the handle. 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
00190776426637MillenniumAvalign Technologies, Inc.LRC2026-08-19
00190776426347MillenniumAvalign Technologies, Inc.LRC2026-08-18
00844505014786FEATHERVAC, ECLIPSEGrace Medical, Inc.LRC2026-08-18
00844505014793FEATHERVAC, ECLIPSE FLAT RIBBONGrace Medical, Inc.LRC2026-08-18
04054462901142evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901159evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901166evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901180evonosevonos GmbH & Co. KGLRC2026-08-18
04054462902170evonosevonos GmbH & Co. KGLRC2026-08-18
04054462902187evonosevonos GmbH & Co. KGLRC2026-08-18
00190776423704MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423711MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423728MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424374MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424381MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424398MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776422653MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422660MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422684MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422462MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422523MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422585MillenniumAvalign Technologies, Inc.LRC2026-07-31
09348811102645INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
09348811102669INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
00198506093593ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093777ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093807ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093814ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
B382SD9200321000Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321060Surgical DirectSurgical Direct, Inc.LRC2026-07-29