FDA.reportPublic FDA data

MORCE POWER

Primary DI
04055207000946
Brand
MORCE POWER
Company
Richard Wolf GmbH
Model
8307011
Catalog number
8307011
Device description
HANDPIECE MAX. 1000RPM for use with rotation morcellators, control by footswitch, 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207000946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207000946040552070009464055207000946

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

Contacts#

Phone, Email table
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
false
Serial number
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

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