FDA.report

NA

Primary DI
04055207008263
Brand
NA
Company
Richard Wolf GmbH
Model
82917
Catalog number
829.17
Device description
FLEX. BIOPSY FORCEPS 7FR WL 375MM straight, double action, TL 497mm, non-dismantling, 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
FCLFORCEPS, BIOPSY, NON-ELECTRIC
HRXArthroscope

Product Code Classifications

CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207008263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207008263040552070082634055207008263

GMDN Terms

TermDefinition
Flexible endoscopic biopsy forceps, reusableA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of 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
Length375Millimeter
Outer Diameter2.33333333333Millimeter

Sterilization Methods

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

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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