FDA.report

NA

Primary DI
04055207039755
Brand
NA
Company
Richard Wolf GmbH
Model
830208
Catalog number
8302.08
Device description
VERES CANNULA Ø 2.1MM WL 80MM with insufflation stopcock and Luer connection, reusable
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FHOpneumoperitoneum needle
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
HRXArthroscope

Product Code Classifications

CodeDeviceSpecialtyClass
FHOPneumoperitoneum NeedleGastroenterology, Urology2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207039755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207039755040552070397554055207039755

GMDN Terms

TermDefinition
Spring-loaded pneumoperitoneum needle, reusableA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a reusable device.

Device Sizes

TypeValueUnit
Length80Millimeter
Outer Diameter2.1Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method
Ethylene Oxide;Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
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
false
Sterilization required before use
true

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