FDA.report

POWER STICK M4

Primary DI
04055207017982
Brand
POWER STICK M4
Company
Richard Wolf GmbH
Model
8564021
Catalog number
8564.021
Device description
MOTOR HANDPIECE MAX. 6000RPM for use with rotation tools, control by footswitch, reusable
Published
2021-05-14
Public version status
New
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
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207017982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207017982040552070179824055207017982

GMDN Terms

TermDefinition
Line-powered surgical power tool system motorA compact line-powered engine (that may include a rechargeable battery) intended to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures that include drilling, sawing, and inserting involving bones and tough tissues (e.g., cartilage, ligaments). It may be available in two different forms: 1) a pistol-like handpiece that connects to a variety of surgical power tool attachments; or 2) a proximal attachment (e.g., micro-motor) to a variety of motorless handpieces. The device may be cannulated to permit use of a guidewire. It may be operated with a hand- or foot-switch. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
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04055207000328NA20301052030.1052023-01-11
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