FDA.reportPublic FDA data

Exchangeable suction-Irrigation tube

Primary DI
04048223006597
Brand
Exchangeable suction-Irrigation tube
Company
Pajunk GmbH Medizintechnologie
Model
1298-00-05
Catalog number
1298-00-05
Device description
Exchangeable suction-Irrigation tube M8 x 1, Ø 5mm, markings and 4 holes at distal end
Published
2016-09-08
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011997000MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XXPajunk GmbH2001-07-10GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223006597PrimaryGS10
04048223083154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223006597040482230065974048223006597
04048223083154040482230831544048223083154

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

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Primary DI, Brand, Model table
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04048223051757SONOPLEX001285-71001285-712021-04-02
04048223051801SONOPLEX001285-77001285-772021-04-02
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04048223102572UNIPLEX® NANOLINE001156-77001156-772021-04-02
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04048223103449SONOPLEX001185-71001185-712021-04-02
04048223103463SONOPLEX001185-74001185-742021-04-02
04048223103562SONOPLEX001187-74001187-742021-04-02
04048223107058SONOTAP1185-3E0501185-3E0502021-04-02
04048223115756TUOHY1150-7G1031150-7G1032021-07-07
04048223116043SONO MSK1191-4C0501191-4C0502021-07-07
04048223116074SONO MSK1191-4E0701191-4E0702021-07-07
04048223116081SONO MSK1191-4E0901191-4E0902021-07-07
04048223116098SONO MSK1191-4E1001191-4E1002021-07-07
04048223116265SONOTAP II1285-3E0501285-3E0502021-07-07
04048223116272SONOTAP II1285-3E0801285-3E0802021-07-07

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