FDA.reportPublic FDA data

BLUEENDO

Primary DI
04251303811886
Brand
BLUEENDO
Company
TROKAMED GmbH
Model
53-000032
Catalog number
501-031-001
Device description
Valve module Ø 10mm, BlueEndo, for Morcellator System with Reducer Ø 10- 5mm single-use, sterile, 5 pcs./box
Published
2023-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251303811886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251303811886042513038118864251303811886

GMDN Terms#

Term, Definition table
TermDefinition
Tissue morcellation systemAn assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
341943858
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091452ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00198506091469ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00817401029161EndoplusEndoplusHET2026-06-05
10653405044703CORE DYNAMICSConmed CorporationHET2026-03-23
10887482155261Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155285Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155308Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
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10381780538776MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
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10381780538837MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538844MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538851Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538899Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538905Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
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10381780538943Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538950Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29