Blue Sky Bio, LLC.

GUDID 00810060220092

BIO | MAX Flat Snap Abutment NP 30 degree, 3.0mm Collar

BLUE SKY BIO LLC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID00810060220092
NIH Device Record Key9ef4dda0-3c3c-4ac9-840a-826d93b8e922
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlue Sky Bio, LLC.
Version Model NumberAGJHN3030
Company DUNS618960848
Company NameBLUE SKY BIO LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100810060220092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-17
Device Publish Date2020-09-09

On-Brand Devices [Blue Sky Bio, LLC.]

00815131027525Z9822C1
00815131027518Z9818C1
00815131027501Z4019D4
00815131027495Z9822D4
00815131027488Z9818D4
00815131027471Z9816D4
00815131027464Z9814D4
00815131027457Z4019D3
00815131027440Z9822D3
00815131027433Z9818D3
00815131027426Z9816D3
00815131027419Z9814D3
00815131027402Z4019D2
00815131027396Z9822D2
00815131027389Z9818D2
00815131027372Z9816D2
00815131027365Z9814D2
00815131027358Z4019C4
00815131027341Z9822C4
00815131027334Z9818C4
00815131027327Z9816C4
00815131027310Z9814C4
00815131027303Z4019C3
00815131027297Z9822C3
00815131027280Z9818C3
00815131027273Z9816C3
00815131027266Z9814C3
00815131027259Z4019C2
00815131027242Z9822C2
00815131027235Z9818C2
00815131027228Z9816C2
00815131027211Z9814C2
00815131027204Z4019C1
00815131027198Z9816C1
00815131027181Z9814C1
00815131027174Z4019B4
00815131027167Z9822B4
00815131027150Z9818B4
00815131027143Z9816B4
00815131027136Z9814B4
00815131027129Z4019B3
00815131027112Z4019B2
00815131027105Z9822B3
00815131027099Z9818B3
00815131027082Z9816B3
00815131027075Z9814B3
00815131027068Z9818B2
00815131027051Z9822B2
00815131027044Z9816B2
00815131027037Z9814B2

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