FDA.reportPublic FDA data

Exchangeable suction-Irrigation tube

Primary DI
04048223029534
Brand
Exchangeable suction-Irrigation tube
Company
Pajunk GmbH Medizintechnologie
Model
1298-00-05OL
Catalog number
1298-00-05OL
Device description
Exchangeable suction-Irrigation tube M8 x 1, Ø 5mm, markings and 4 holes at distal end Olympus-ID: A5798
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
04048223029534PrimaryGS10
04048223083178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223029534040482230295344048223029534
04048223083178040482230831784048223083178

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223056165VASCULAR SONO1187-4F0351187-4F0352021-04-02
04048223056172VASCULAR SONO1187-4F0701187-4F0702021-04-02
04048223056189VASCULAR SONO1187-4K0401187-4K0402021-04-02
04048223056196VASCULAR SONO1187-4K0701187-4K0702021-04-02
04048223056202VASCULAR SONO1187-4K1001187-4K1002021-04-02
04048223115947VASCULAR SONO1187-4F0351187-4F0352021-07-07
04048223115954VASCULAR SONO1187-4F0701187-4F0702021-07-07
04048223115961VASCULAR SONO1187-4K0401187-4K0402021-07-07
04048223115978VASCULAR SONO1187-4K0701187-4K0702021-07-07
04048223115985VASCULAR SONO1187-4K1001187-4K1002021-07-07
04048223126561VascularSono1187-4K0701187-4K0702025-06-17
04048223126653VascularSono1187-4K1001187-4K1002025-11-04
04048223126721VascularSono1187-4F0701187-4F0702025-11-04
14048223021153VascularSono1187-4K0701187-4K0702016-08-31
14048223021160VascularSono1187-4K1001187-4K1002016-08-31
14048223021344VascularSono1187-4F0351187-4F0352016-08-31
14048223021504VascularSono1187-4K0401187-4K0402016-08-31
14048223021603VascularSono1187-4F0701187-4F0702016-08-31
04048223122655Tuohy II1170-6I0911170-6I0912026-10-22
04048223122679Tuohy II1170-6K0811170-6K0812026-10-22

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Primary DI, Brand, Company table
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B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
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