Next Gen Driver

GUDID M791NGD10000

BIOACCESS INC

Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Primary Device IDM791NGD10000
NIH Device Record Key7930e25a-604e-4b21-8d8f-fbb83610fc91
Commercial Distribution StatusIn Commercial Distribution
Brand NameNext Gen Driver
Version Model NumberNGD1000
Company DUNS942203001
Company NameBIOACCESS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM791NGD10000 [Primary]

FDA Product Code

GFFBur, Surgical, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-12
Device Publish Date2022-08-04

On-Brand Devices [Next Gen Driver]

M791NGD1005A0NGD1005A
M791NGD10000NGD1000

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