FDA.reportPublic FDA data

TEKNO®

Primary DI
04044684007258
Brand
TEKNO®
Company
Tekno-Medical Optik-Chirurgie GmbH
Model
8463-16
Catalog number
tk 8463-16
Device description
KELLY FISTULA SCISSORS CURVED 16CM
Published
2024-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGNScissors, Surgical Tissue, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04044684007258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04044684007258040446840072584044684007258

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. 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
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
04059453162762Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEGN2026-05-29
G149NPGFS0NPSACME ENTERPRISE.EGN2026-05-01
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