FDA.report

NA

Primary DI
04055207063453
Brand
NA
Company
Richard Wolf GmbH
Model
3000950
Catalog number
3000950
Device description
ESWL TREATMENT TABLE Multifunctional treatment table for Lithotripsy / Endourology, U: 100 -240VAC, 50/60Hz, Dim (wxhxl) 756x745-945x1800-2400mm
Published
2024-05-21
Public version status
New
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
GDCTable, operating-room, electrical

Product Code Classifications

CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207063453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207063453040552070634534055207063453

GMDN Terms

TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Storage And Handling

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

Sterilization Methods

Method

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
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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04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
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04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

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