FDA.report

NA

Primary DI
04055207009734
Brand
NA
Company
Richard Wolf GmbH
Model
829651
Catalog number
8296.51
Device description
COTTON APPLICATOR Ø 3.4MM WL 490MM TL 605mm
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
KCJAPPLICATOR, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207009734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207009734040552070097344055207009734

GMDN Terms

TermDefinition
Flexible endoscopic sponge/swab forcepsA flexible manual device intended to be 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 a reusable device.

Device Sizes

TypeValueUnit
Length490Millimeter
Outer Diameter3.4Millimeter

Sterilization Methods

Method
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
true
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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