FDA.report

NA

Primary DI
04055207057100
Brand
NA
Company
Richard Wolf GmbH
Model
2207011
Catalog number
2207.011
Device description
SUCTION PUMP for US Litho 2271, with speed control for pressure setting between 0.1 and 0.6 bar, U: 100-230VAC/ 50/60Hz, Dim. (wxhxd): 320x120x225mm
Published
2017-07-21
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
JCXAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
JCXApparatus, Suction, Ward Use, Portable, Ac-PoweredGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207057100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207057100040552070571004055207057100

GMDN Terms

TermDefinition
Surgical fluid/smoke waste management system suction unitA mobile, mains electricity (AC-powered) device assembly designed to collect surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a suction pump, tubing, collection containers, a vacuum gauge, a vacuum control knob, an overflow trap, and a special filter for smoke evacuation. It uses negative pressure (suction) at the site of intervention to collect fluid in its collection containers and filter captured smoke with its filters. It is attached to a dedicated disposal unit for automatic container emptying and cleaning to prepare for the next use.

Sterilization Methods

Method

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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04055207069813NA8924084228924084222026-01-14
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04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
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