SB-60HR

GUDID 08800046027397

GNI Co.,Ltd

Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable
Primary Device ID08800046027397
NIH Device Record Key9628660f-3e26-4a58-a5ba-aad7522d6daa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSB-60HR
Version Model NumberSB-60HR
Company DUNS694828541
Company NameGNI Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800046027397 [Primary]

FDA Product Code

HRTStripper, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


[08800046027397]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-19
Device Publish Date2023-10-11

Devices Manufactured by GNI Co.,Ltd

08800046000642 - SA1208C2024-01-03
08800046000659 - SA1210C2024-01-03
08800046000666 - SA1406C2024-01-03
08800046000673 - SA1408C2024-01-03
08800046000680 - SA1410C2024-01-03
08800046000697 - SA1606C2024-01-03
08800046000703 - SA1608C2024-01-03
08800046000710 - SA1610C2024-01-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.