Primary Device ID | 00815131022070 |
NIH Device Record Key | a62ecd4b-e26d-45f1-ab33-00cd8df07a06 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Blue Sky Bio, LLC |
Version Model Number | ITT4316 |
Company DUNS | 618960848 |
Company Name | BLUE SKY BIO LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815131022070 [Primary] |
DZE | Implant, Endosseous, Root-Form |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00815131022070]
Radiation Sterilization
[00815131022070]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-10-18 |
Device Publish Date | 2015-10-24 |
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00810060225974 - Blue Sky Bio, LLC. | 2024-06-06 Stop/Guide Sleeve 10mm Stop Depth |
00810060225981 - Blue Sky Bio, LLC. | 2024-06-06 Stop/Guide Sleeve 11.5mm Stop Depth |
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00810060226001 - Blue Sky Bio, LLC. | 2024-06-06 Guided Variable Interchangeable Stop Drill Ø2.0 |
00810060226018 - Blue Sky Bio, LLC. | 2024-06-06 Guided Variable Interchangeable Stop Drill Ø2.5 |