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
00810220800294Adler Instrument CompanyAdler, Inc.KAE2026-06-02
09348811022066INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-06-02
09348811105417INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-05-29
09348811103796INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104236INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104595INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104908INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104915INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104953INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105653INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105707INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172099INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172112INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-18
G04371902F0BEARBear-Ent, LLCKAE2026-02-12
09348811105400INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-21
09348811129024INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-19
08906039316018OSSEOUS Titanium-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316025OSSEOUS Fluoroplastic-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316032OSSEOUS Stapes Prosthesis Crimping ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316049OSSEOUS Tilley's Nasal Dressings Forceps EON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039319699OSSEOUS Micro Alligator Ear ForcepesEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
G586NS80152710Novo SurgicalNOVO SURGICAL, INC.KAE2024-02-22
07898506842704QuinelatoSchobell Industrial LtdaKAE2023-01-09
10381780406815Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-08-16
10381780407072Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-08-16
10381780402855Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402954Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402961Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402985Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03