FDA.report

Resectoscopy working unit,passive, closed handle,24/26/28.5Ch

Primary DI
EMAH36005011
Brand
Resectoscopy working unit,passive, closed handle,24/26/28.5Ch
Company
mahe medical gmbh
Model
36.005.01
Catalog number
36.005.01
Device description
Resectoscopy working unit,passive, closed handle,24/26/28.5Ch
Published
2016-08-03
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
JFLPH RATE MEASUREMENT, CARBON-DIOXIDE

Product Code Classifications

CodeDeviceSpecialtyClass
JFLPh Rate Measurement, Carbon-DioxideClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EMAH36005011PackageHIBCC1In Commercial Distribution
EMAH36005010PrimaryHIBCC0

GMDN Terms

TermDefinition
Rigid endoscope working guideAn endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+49(0)746592750info@mahe-med.de

Regulatory Flags

DUNS number
342243334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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
true
Sterilization required before use
false

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04050659162112mahe medical GmbH001-0001-018XS2019-11-05
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