FDA.reportPublic FDA data

Trokamed

Primary DI
04251303804239
Brand
Trokamed
Company
TROKAMED GmbH
Model
DIL15006
Catalog number
DIL15006
Device description
Obturator for Dilator Ø 5mm
Published
2024-07-19
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
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251303804239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251303804239042513038042394251303804239

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, reusableA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. 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
Premarket exempt
true
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
04251303817659TrokamedUUM00198UUM001982025-05-21
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
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
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00190776418441MillenniumAvalign Technologies, Inc.NWV2026-03-25
00848657078269AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-03-02
00190776417390MillenniumAvalign Technologies, Inc.NWV2026-02-27
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00198506088520ELMED INCORPORATEDELMED INCORPORATEDNWV2026-02-23
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00848657078108AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078115AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
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00848657077958AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657077965AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
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00198506086489ELMED INCORPORATEDELMED INCORPORATEDNWV2025-11-05
00190776414344MillenniumAvalign Technologies, Inc.NWV2025-10-23
00190776413910MillenniumAvalign Technologies, Inc.NWV2025-10-21
00190776413958MillenniumAvalign Technologies, Inc.NWV2025-10-21
00848657077682AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2025-10-15