FDA.reportPublic FDA data

FlowSys Tube

Primary DI
04048223027523
Brand
FlowSys Tube
Company
Pajunk GmbH Medizintechnologie
Model
1298-00-06L
Catalog number
1298-00-06L
Device description
FlowSys Tube Exchangeable suction-irrigation tube M8 x 1, Ø 5mm, markings and
Published
2019-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04048223027523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223027523040482230275234048223027523

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223126103NerveStim Pure1151-94-901151-94-902026-02-06
04048223128817SPROTTE®511151-29A511151-29A2025-09-16
04048223129111SPROTTE® NRFit051163-29A051163-29A2025-09-16
04048223129517SPROTTE® NRFit041163-29A041163-29A2025-09-16
04048223129647SPROTTE®071151-30C071151-30C2025-09-16
04048223129678SPROTTE® NRFit021163-30C021163-30C2025-09-16
04048223129692SPROTTE® NRFit031163-27A031163-27A2025-09-16
04048223129838SPROTTE® NRFit061163-29A061163-29A2025-09-16
04048223129999Standard Sprotte Needle321151-29A321151-29A2025-09-16
04048223131398Standard Sprotte Needle341151-31B341151-31B2025-09-16
04048223131428SPROTTE®131151-30C131151-30C2025-09-16
04048223131442SPROTTE®131151-30A131151-30A2025-09-16
04048223131466SPROTTE®141151-30C141151-30C2025-09-16
04048223132050SonoPlex® II Facet S001287-72001287-722025-09-16
04048223132135SonoPlex® II Facet S001287-76001287-762025-09-16
04048223132241SonoPlex® II Facet NRFit001265-74001265-742025-09-16
04048223132319SonoPlex® II Facet NRFit001265-77001265-772025-09-16
04048223132395SonoPlex® II Facet001285-76001285-762025-09-16
04048223132463SonoBlock II Facet001280-74001280-742025-09-16
04048223132562SonoPlex® II Facet S NRFit001267-76001267-762025-09-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403261ActivSight Laparoscope 10mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
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