FDA.report

Blue Sky Bio, LLC.

Primary DI
00810060220405
Brand
Blue Sky Bio, LLC.
Company
BLUE SKY BIO LLC
Model
DRILLT35S
Device description
Drill T 3.5mm Short
Published
2021-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
EBLPin, Retentive And Splinting, And Accessory Instruments

Product Code Classifications

CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810060220405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060220405008100602204058100602204050810060220405

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
618960848
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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