FDA.report

ERBE

Primary DI
04050147007611
Brand
ERBE
Company
Erbe Elektromedizin GmbH
Model
20325-100
Device description
EIP 2 One pedal footswitch AP IP X8 Equipment
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FQHLavage, Jet

Product Code Classifications

CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050147007611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050147007611040501470076114050147007611

GMDN Terms

TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat and direct sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods

Method

Regulatory Flags

DUNS number
316116623
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
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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04050147023529Erbe20160-01120160-0112025-04-07
04050147023581Erbe20132-32120132-3212025-02-11
04050147023666Erbe20132-32320132-3232025-02-11
04050147023642Erbe20132-32420132-3242025-02-11
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04050147022768Erbe20220-11020220-1102025-01-21
04050147022775Erbe20220-00020220-0002025-01-21
04050147022782Erbe20220-01020220-0102025-01-21
04050147023543Erbe20220-00120220-0012025-01-21
04050147023550Erbe20220-01120220-0112025-01-21
04050147023567Erbe20220-10120220-1012025-01-21

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