FDA.report

NA

Primary DI
04055207040140
Brand
NA
Company
Richard Wolf GmbH
Model
838394
Catalog number
8383.94
Device description
SUCT./IRRIG. TUBE Ø 5MM WL 300MM reusable
Published
2016-09-28
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
GCJLaparoscope, general & plastic surgery
JOLCATHETER AND TIP, SUCTION

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207040140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207040140040552070401404055207040140

GMDN Terms

TermDefinition
Surgical irrigation/aspiration handpiece, reusableA hand-held device designed to be used for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is fitted with a long syringe-like nozzle that is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., clamps, filters, spikes) are not included (i.e., not a tubing set). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery; it is not an ophthalmic device. This is a reusable device.

Device Sizes

TypeValueUnit
Length300Millimeter
Outer Diameter5Millimeter

Sterilization Methods

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

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
true
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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