BL MINI KIT

GUDID 06947600304388

BIO CONCEPT Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID06947600304388
NIH Device Record Key37e63dca-1c1a-417b-9db7-4680c9ee3afa
Commercial Distribution StatusIn Commercial Distribution
Brand NameBL MINI KIT
Version Model Number156200
Company DUNS527603266
Company NameBIO CONCEPT Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600304388 [Primary]

FDA Product Code

NYEFixture Mount Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


[06947600304388]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

Devices Manufactured by BIO CONCEPT Co., Ltd.

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06936616987753 - Dome Drill,Φ7.0mm, L26mm2025-04-02
06936616987760 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L31mm2025-04-02
06936616987777 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L37mm2025-04-02
06936616987784 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L31mm2025-04-02
06936616987791 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L37mm2025-04-02
06936616987807 - Osteotome maxillary sinus elevation Drill,Φ3.3mm, L31mm2025-04-02

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