FDA.report

NA

Primary DI
04055207014066
Brand
NA
Company
Richard Wolf GmbH
Model
8137041
Catalog number
8137.041
Device description
STONE BASKET 4FR WL 660MM four-armed, TL 717mm, take-apart, 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
FFLDISLODGER, STONE, BASKET, URETERAL, METAL

Product Code Classifications

CodeDeviceSpecialtyClass
FFLDislodger, Stone, Basket, Ureteral, MetalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207014066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207014066040552070140664055207014066

GMDN Terms

TermDefinition
Stone/foreign-body extraction setA collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. This is a reusable device.

Device Sizes

TypeValueUnit
Length660Millimeter
Outer Diameter1.33333333333Millimeter

Sterilization Methods

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

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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03600040955758Dormia N.StoneColoplast A/SFFL2024-04-05
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