FDA.reportPublic FDA data

Blue Sky Bio, LLC.

Primary DI
00815131028928
Brand
Blue Sky Bio, LLC.
Company
BLUE SKY BIO LLC
Model
DJT50S
Device description
BIO Trilobe Implant Driver 5.0mm Short
Published
2021-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
EBLPin, Retentive And Splinting, And Accessory Instruments

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815131028928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815131028928008151310289288151310289280815131028928

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench adaptorA component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use only. It may be referred to as a driver. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618960848
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810060227060Blue Sky Bio, LLCIJHTP30102026-04-22
00810060227077Blue Sky Bio, LLCIJHTP30112026-04-22
00810060227084Blue Sky Bio, LLCIJHTP30132026-04-22
00810060227091Blue Sky Bio, LLCIJHTP30162026-04-22
00810060227107Blue Sky Bio, LLCIJHTP35082026-04-22
00810060227114Blue Sky Bio, LLCIJHTP35102026-04-22
00810060227121Blue Sky Bio, LLCIJHTP35112026-04-22
00810060227138Blue Sky Bio, LLCIJHTP35132026-04-22
00810060227145Blue Sky Bio, LLCIJHTP35162026-04-22
00810060227152Blue Sky Bio, LLCIJHTP43062026-04-22
00810060227169Blue Sky Bio, LLCIJHTP43082026-04-22
00810060227176Blue Sky Bio, LLCIJHTP43102026-04-22
00810060227183Blue Sky Bio, LLCIJHTP43112026-04-22
00810060227190Blue Sky Bio, LLCIJHTP43132026-04-22
00810060227206Blue Sky Bio, LLCIJHTP43162026-04-22
00810060227213Blue Sky Bio, LLCIJHTP50062026-04-22
00810060227220Blue Sky Bio, LLCIJHTP50082026-04-22
00810060227237Blue Sky Bio, LLCIJHTP50102026-04-22
00810060227244Blue Sky Bio, LLCIJHTP50112026-04-22
00810060227251Blue Sky Bio, LLCIJHTP50132026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060227046Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2026-02-10
00810060225967Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225974Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225981Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225998Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226001Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226018Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226025Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226032Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
08800075620965OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
08800075620972OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
00810060225721Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2023-11-09
05060489370006StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370013StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370037StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370044StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370068StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370075StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370020StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
00560489370020StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370181StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370174StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370051StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370204Stabilok drillFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370198Stabilok drillFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
D2483801802Markley Threaded Wire .018HAGER WORLDWIDE, INC.EBL2023-04-10
D248380220Markley Threaded Wire .022HAGER WORLDWIDE, INC.EBL2023-04-10
D2483802500Markley Threaded Wire .025HAGER WORLDWIDE, INC.EBL2023-04-10
D2483802702Markley Threaded Wire .027HAGER WORLDWIDE, INC.EBL2023-04-10
D248380300Markley Threaded Wire .030HAGER WORLDWIDE, INC.EBL2023-04-10