FDA.reportPublic FDA data

TEKNO®

Primary DI
04044684013938
Brand
TEKNO®
Company
Tekno-Medical Optik-Chirurgie GmbH
Model
12041-16
Catalog number
tk 12041-16
Device description
KELLY-RANKIN HAEMOSTATIC FORCEPS CURVED 16CM
Published
2024-05-13
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
HRQHemostat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04044684013938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04044684013938040446840139384044684013938

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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
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
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
00810143909197SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909265SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909302SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909616SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931777SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931784SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931791SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931807SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931814SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931906SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931920SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931937SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931944SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931951SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931968SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212935089SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143907438SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908725SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908732SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908749SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908756SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909722SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909739SURGIPROSSurgipros, LLCHRQ2026-07-30
00840183532321BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00840183533076BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00810055258567Surgical DesignSurgical Design, Inc.HRQ2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.HRQ2026-06-22
05060212051103Crile Artery Forceps, 145mm StraightDTR MEDICAL LIMITEDHRQ2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatDTR MEDICAL LIMITEDHRQ2026-06-10
05060411984639Baby Overholt Artery Forceps Curved, 140mmDTR MEDICAL LIMITEDHRQ2026-06-10