FiberLocker PowerUnit - Handpiece

GUDID 07649988202278

ZuriMED Technologies AG

Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Primary Device ID07649988202278
NIH Device Record Keye97f394c-9104-4d13-ad09-f71f651242fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiberLocker PowerUnit - Handpiece
Version Model NumberPU7050A1
Company DUNS480096456
Company NameZuriMED Technologies AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107649988202278 [Primary]

FDA Product Code

KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07649988202278]

Moist Heat or Steam Sterilization


[07649988202278]

Moist Heat or Steam Sterilization


[07649988202278]

Moist Heat or Steam Sterilization


[07649988202278]

Moist Heat or Steam Sterilization


[07649988202278]

Moist Heat or Steam Sterilization


[07649988202278]

Moist Heat or Steam Sterilization


[07649988202278]

Moist Heat or Steam Sterilization


[07649988202278]

Moist Heat or Steam Sterilization


[07649988202278]

Moist Heat or Steam Sterilization


[07649988202278]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-10
Device Publish Date2026-02-02

Devices Manufactured by ZuriMED Technologies AG

07649988202209 - FiberLocker PowerUnit - Transfer Shield2026-02-10
07649988202278 - FiberLocker PowerUnit - Handpiece2026-02-10
07649988202278 - FiberLocker PowerUnit - Handpiece2026-02-10
07649988202285 - FiberLocker PowerUnit - Motor Pack2026-02-10
07649988202292 - FiberLocker PowerUnit - Charging Station2026-02-10
07649988202230 - ZuriMED Technologies AG2025-02-18 ZuriMED Technologies AG - FiberLocker Implant (SpeedPatch PET)
07649988202247 - ZuriMED Technologies AG2025-02-18 ZuriMED Technologies AG - FiberLocker Instrument SN

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