FDA.report

NA

Primary DI
04055207039717
Brand
NA
Company
Richard Wolf GmbH
Model
829535
Catalog number
8295.35
Device description
COTTON APPLICATOR Ø 3.0MM WL 350MM reusable
Published
2016-09-23
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
EOXEsophagoscope (flexible or rigid)

Product Code Classifications

CodeDeviceSpecialtyClass
EOXEsophagoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207039717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207039717040552070397174055207039717

GMDN Terms

TermDefinition
Endoscopic sponge forcepsA flexible manual device used in combination with a compatible endoscope (e.g., a gastroscope) to carry an absorbent pad of folded gauze or cotton into the site of intervention. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like grasping tongs which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is reusable device.

Device Sizes

TypeValueUnit
Length350Millimeter
Outer Diameter3Millimeter

Sterilization Methods

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

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
true
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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