FDA.reportPublic FDA data

TEKNO®

Primary DI
04044684009177
Brand
TEKNO®
Company
Tekno-Medical Optik-Chirurgie GmbH
Model
9434-11
Catalog number
9434-11
Device description
IRIS SCISSORS CURVED 11,5CM
Published
2023-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04044684009177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04044684009177040446840091774044684009177

GMDN Terms#

Term, Definition table
TermDefinition
Corneal scissors, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut corneal tissue (e.g., during cataract extraction surgery, corneal transplant surgery). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. This is a reusable device.

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
04044684066392TEKNO®50459-1650459-162025-11-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059453161574Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2026-06-03
04251047920554Vannas Capsulotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047921278Metzenbaum ScissorsA1 Medical GmbHHNF2026-05-29
04251047931680Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047931697Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047932021Super-Cut Stevens Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936395Vitrectomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936432Gerten Iridectomy ScissorA1 Medical GmbHHNF2026-05-29
G346EA4018GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2026-04-23
G2231349550Ophthalmic ScissorsMedetz Surgical Instruments LLCHNF2026-04-09
09348811004192INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
09348811004260INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
G346EA40SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-10-29
G346EA0823GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-09-29
07612717071643FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071704FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071735FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
08052276028358Retinal Tip 23G Microscissors CurvedAKTIVE SRLHNF2024-01-15
08052276028372Retinal Tip 25G Microscissors CurvedAKTIVE SRLHNF2024-01-15
08052276028464Retinal Tip vertical 20GAKTIVE SRLHNF2024-01-15
08052276028488Retinal Tip vertical 23GAKTIVE SRLHNF2024-01-15
08052276028501Retinal Tip vertical 25GAKTIVE SRLHNF2024-01-15
0805227602804455° Rotary microscissor 20G only Tip AKTIVE SRLHNF2024-01-11
08052276028129Retinal Tip 20G Microscissors CurvedAKTIVE SRLHNF2024-01-11
08052276028143Retinal Tip 20G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028310Retinal Tip 23G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028334Retinal Tip 25G Microscissors StraightAKTIVE SRLHNF2024-01-11
08175700144605Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700144612Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145206Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10