FDA.reportPublic FDA data

Sterile Disposable Button Cannula, 45 mm length

Primary DI
04260462742825
Brand
Sterile Disposable Button Cannula, 45 mm length
Company
Pemax Kunststoff GmbH
Model
KK45R21S
Catalog number
KK45R21S
Device description
Sterile Disposable Button Cannula, 45 mm length
Published
2024-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260462742832PackageGS135In Commercial Distribution
04260462742825PrimaryGS10
04260462741392Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260462742832042604627428324260462742832
04260462742825042604627428254260462742825
04260462741392042604627413924260462741392

GMDN Terms#

Term, Definition table
TermDefinition
Wound irrigation cannulaA rigid or semi-rigid tube intended to be connected to a parent device (e.g., syringe) to channel irrigation fluids (e.g., saline solution) to a skin or surgical wound for washing and removing debris; it is not intended for aspiration of fluids. This is a single-use device intended to be used in a sterile condition.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4974415204900info@pemax.de

Regulatory Flags#

DUNS number
341672714
Device count
21
Premarket exempt
true
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
04260462743853"Sterile Drape for ""SCOUT ARM"""12935.BUY05492025-03-18
04260462743914"Steile Drape for ""Surgical Arm"""12935.BUY05482025-03-18
04260462743945"Steile Drape for ""CONTROL SCREEN"""12935.BUY05462025-03-18
04260462743877Sterile Drape for "SCOUT ARM"12935.BUY05492025-03-18
04260462743907"Steile Drape for ""Cart"""12935.BUY08872025-03-18
04260462743938Steile Drape for "Surgical Arm"12935.BUY05482025-03-18
04260462743969Steile Drape for "CONTROL SCREEN"12935.BUY05462025-03-18
04260462740357Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mm12741.1236412741.123642024-06-05
04260462740524HMD cover set, consisting of 2 lens protective caps made of PP, color white12741.1236512741.123652024-06-05
04260462741279PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./oranPC2-SD-3PC2-SD-32024-06-05
04260462742160Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm12741.1387312741.138732024-06-05
04260462742405PEMICLIP - C-arm sterile cover set, widened frame cover with 6 clips PC3-SCSA-3 PC3-SCSA-3PC3-SCSA-32024-06-05
04260462742467PEMIDrape - C-arm sterile cover, metal temple cover blue line, Art.Nr. SP-CS-SD-SP-CS-SD-3SP-CS-SD-32024-06-05
04260462742528PEMIDrape - C-arm sterile cover set, metal temple cover blue line, Art.Nr. SP-CASP-CA-3SP-CA-32024-06-05
04260462742917"Smart Control Sterile Cover for Remote Control VB10 ""VB10-SC"""VB10-SCVB10-SC2024-06-05
04260462743006PEMICLIP - C-arm sterile cover set, widened frame cover with 6 clips PC3-VB10-3PC3-VB10-3PC3-VB10-32024-06-05
04260462743037"Sterile Cover for Remote Control Unit Drape Set ""VB10-RC"""VB10-RCVB10-RC2024-06-05
04260462742689Sterile Disposable Button Cannula, 100 mm lengthKK100L21SKK100L21S2024-06-05
04260462742702Sterile Disposable Button Cannula, 70 mm lengthKK70L150SKK70L150S2024-06-05
04260462742740Sterile Disposable Button Cannulas, 70 mm lengthKK70L50SKK70L50S2024-06-05

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08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07