Blue Sky Bio, LLC

GUDID 00810060222164

Impression Coping Internal Hex Level 3.5mm Platform

BLUE SKY BIO LLC

Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog
Primary Device ID00810060222164
NIH Device Record Keyca25bc76-4159-4487-8f88-e736d4d7b21e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlue Sky Bio, LLC
Version Model NumberMIH3500
Company DUNS618960848
Company NameBLUE SKY BIO LLC
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 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
GS100810060222164 [Primary]

FDA Product Code

EBLPin, Retentive And Splinting, And Accessory Instruments

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-21
Device Publish Date2021-07-13

On-Brand Devices [Blue Sky Bio, LLC]

00815131022308IOW4114
00815131022292IOW4112
00815131022285IOW4110
00815131022278IOW4108
00815131022209ITW5614
00815131022193ITW5612
00815131022186ITW5610
00815131022179ITW5608
00815131022162ITT6013
00815131022155ITT6011
00815131022148ITT6010
00815131022131ITT6008
00815131022124ITT5016
00815131022117ITT5013
00815131022100ITT5011
00815131022094ITT5010
00815131022087ITT5008
00815131022063ITT4313
00815131022056ITT4311
00815131022049ITT4310
00815131022032ITT4308
00815131022025ITT3516
00815131022018ITT3513
00815131022001ITT3511
00815131021998ITT3510
00815131021981ISQ4816
00815131021974ISQ4814
00815131021967ISQ4812
00815131021950ISQ4810
00815131021943ISQ4808
00815131021936ISQ4116
00815131021929ISQ4114
00815131021912ISQ4112
00815131021905ISQ4110
00815131021899ISQ4108
00815131021882ISQ3316
00815131021875ISQ3314
00815131021868ISQ3312
00815131021851ISQ3310
00815131021844ISQ3308
00815131021837IOWS
00815131021820IOW4814
00815131021813IOW4812
00815131021806IOW4810
00815131021790IOW4808
00815131021783IORS
00815131021776IORL4116
00815131021769IORL4114
00815131021752IORL4112
00815131021745IORL4110

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.