FDA.report

NA

Primary DI
04055207001233
Brand
NA
Company
Richard Wolf GmbH
Model
83070115
Catalog number
83070115
Device description
O-RING FOR MORCELLATOR HANDPIECE reusable
Published
2016-09-29
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
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207001233PrimaryGS10
04055207059470Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207001233040552070012334055207001233
04055207059470040552070594704055207059470

GMDN Terms

TermDefinition
Tissue morcellation systemAn assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.

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
10
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
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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