Small Bone Tool

GUDID M791SBT10010

BIOACCESS INC

Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Primary Device IDM791SBT10010
NIH Device Record Key57bbf0cc-e9ec-4ed1-b1f9-84762d3be41c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmall Bone Tool
Version Model NumberSBT1001
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
HIBCCM791SBT10010 [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 [Small Bone Tool]

M791SBT1005HTA0SBT1005HTA
M791SBT10050620SBT1005062
M791SBT10050SBT1005
M791SBT10040SBT1004
M791SBT1001A0SBT1001A
M791SBT10010SBT1001
M791SBT1000HT0SBT1000HT
M791SBT10000SBT1000

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