FDA.reportPublic FDA data

Trokamed

Primary DI
04251303817659
Brand
Trokamed
Company
TROKAMED GmbH
Model
UUM00198
Catalog number
UUM00198
Device description
Cold knife, half round
Published
2025-05-21
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251303817659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251303817659042513038176594251303817659

GMDN Terms#

Term, Definition table
TermDefinition
UrethrotomeA surgical instrument designed like a long catheter or thin flexible endoscope shape with a lateral moveable small knife at the distal end which is used for incising strictures in the urethra, (the duct by which urine is discharged from the bladder). This operation may be performed either "blind", where the surgeon cannot see the site, or with the help of endoscopic instruments. Some device designs may incorporate an optical channel for endoscopic visual control. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49770492440sales@trokamed.de

Regulatory Flags#

DUNS number
341943858
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251303822769BLUEENDO55-15200155-1520012026-03-03
04251303824961BLUEENDO55-00005155-0000512026-02-27
04251303824978BLUEENDO55-15200655-1520062026-02-27
04251303824985BLUEENDO20-13551020-1355102026-02-27
04251303808701TrokamedURE02798URE027982025-05-21
04251303809081TrokamedUUM00197UUM001972025-05-21
04251303811190blueendo02-0008902-000892025-04-04
04251303811572blueendo02-0009002-000902025-04-04
04251303822257blueendo02-0008802-000882025-04-04
04251303822264blueendo02-0009102-000912025-04-04
04251303822288blueendo02-0009502-000952025-04-04
04251303822417blueendo02-0008702-000872025-04-04
04251303804239TrokamedDIL15006DIL150062024-07-19
04251303804246TrokamedDIL15095DIL150952024-07-19
04251303822080BLUEENDO55-122005501-040-4112023-09-19
04251303822097BLUEENDO55-152005501-040-421 2023-09-19
04251303822103BLUEENDO55-202005501-040-431 2023-09-19
04251303810841TrokamedWA2PD18AWA2PD18A2023-07-10
04251303810865TrokamedWA2PS18SWA2PS18S2023-07-10
04251303810872TrokamedWA2PS18LWA2PS18L2023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01