FDA.reportPublic FDA data

TEKNO®

Primary DI
04044684066392
Brand
TEKNO®
Company
Tekno-Medical Optik-Chirurgie GmbH
Model
50459-16
Catalog number
50459-16
Device description
HARTMANN EAR FORCEPS 16CM
Published
2025-11-20
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
KAEForceps, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04044684066392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04044684066392040446840663924044684066392

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49746117010mail@tekno-medical.com

Regulatory Flags#

DUNS number
318762069
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
04044684086499Tekno39172-01tk 39172-012026-01-27
04044684086536Tekno39178-01tk 39178-012026-01-27
04044684004950TEKNO®8035-13tk 8035-132024-09-05
04044684005957TEKNO® 8323-14tk 8323-142024-09-05
04044684007258TEKNO®8463-16tk 8463-162024-09-05
04044684023623TEKNO®20512-1820512-182024-09-05
04044684033301TEKNO®24606-03tk 24606-032024-09-05
04044684077749TEKNO®70120-10S70120-10S2024-09-05
04044684077763TEKNO®70120-150tk 70120-1502024-09-05
04044684078036TEKNO®70120-65tk 70120-652024-09-05
04044684449263TEKNO®Z0000122838tk Z00001228382024-09-05
04044684007432TEKNO®8587-16tk 8587-162024-05-13
04044684007661TEKNO®8652-10tk 8652-102024-05-13
04044684008545TEKNO®8857-17tk 8857-172024-05-13
04044684010968TEKNO®10500-12tk 10500-122024-05-13
04044684013914TEKNO®12040-16tk 12040-162024-05-13
04044684013938TEKNO®12041-16tk 12041-162024-05-13
04044684075660TEKNO®70075-12tk 70075-122024-05-13
04044684075899TEKNO®70100-29tk 70100-292024-05-13
04044684075905TEKNO®70100-30tk 70100-302024-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267926Snowden-PencerSTERIS Deutschland GmbHKAE2026-09-25
00724995271466V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995274955V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275013V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275020V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275037V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275044V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275051V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275068V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275075V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995330002V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
04046826110932MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2026-09-24
G141550875300Carnegie Surgical LLCCarnegie Surgical LLCKAE2026-09-19
00190776420413MillenniumAvalign Technologies, Inc.KAE2026-08-26
00190776420420MillenniumAvalign Technologies, Inc.KAE2026-08-26
04054462901692evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901708evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901715evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901722evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901739evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901746evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901760evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901807evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903160evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903177evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903184evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903191evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903207evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905591evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905607evonosevonos GmbH & Co. KGKAE2026-08-21