FDA.report

NA

Primary DI
04055207040232
Brand
NA
Company
Richard Wolf GmbH
Model
840310
Catalog number
8403.10
Device description
BIOPSY FORCEPS WITH SPIKE Ø 4.5MM for retraction, double opening, WL 130mm, reusable
Published
2016-09-28
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
HRXARTHROSCOPE
NBHAccessories, arthroscopic

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207040232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207040232040552070402324055207040232

GMDN Terms

TermDefinition
Rigid endoscopic biopsy forceps, reusableA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter4.5Millimeter

Sterilization Methods

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

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
false
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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