FDA.report

NA

Primary DI
04055207011232
Brand
NA
Company
Richard Wolf GmbH
Model
883660
Catalog number
8836.60
Device description
COVER PLATE with observation window, for handpiece 8836.90, reusable
Published
2016-09-26
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
GCMENDOSCOPE, RIGID

Product Code Classifications

CodeDeviceSpecialtyClass
GCMEndoscope, RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207011232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207011232040552070112324055207011232

GMDN Terms

TermDefinition
Rectosocope/proctoscope handle end-capA small cap intended to be fitted to the proximal end of the handle of a rectoscope or proctoscope during an examination procedure to provide an airtight seal so that air can be pumped through the scope to inflate the bowel; it typically includes a transparent observation window. This is a reusable device.

Sterilization Methods

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

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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