FDA.report

ECO BALLOON URO

Primary DI
04048223020982
Brand
ECO BALLOON URO
Company
Pajunk GmbH Medizintechnologie
Model
1285-70-11S
Catalog number
1285-70-11S
Device description
1285-70-11S
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14048223020989PreviousGS10
04048223058091PrimaryGS10
04048223020982Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1404822302098914048223020989
04048223058091040482230580914048223058091
04048223020982040482230209824048223020982

GMDN Terms

TermDefinition
Laparoscopic access cannula anchor, single-useA small, sterile, luminal device designed to enable a laparoscopic access cannula (port) to be secured to the skin/tissue of an incision site during a laparoscopic surgical procedure. The outer surface is typically textured/ribbed and intended to grip the tissue whilst the laparoscopic access cannula is inserted through the device lumen and fixed at the required insertion depth using a clamping/locking mechanism. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags

DUNS number
317654283
Device count
5
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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