Blue Sky Bio, LLC.

FDA UDI

Class I (US FDA UDI)

by Blue Sky Bio Llc

Identity

Trade Name: Blue Sky Bio, LLC. FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Device Name: Bio|Pterygoid Guided Drill Ø2.7/3.4 x 12mm Lg FDA UDI
Model / Reference: DRILGP273412 FDA UDI
Description: Bio|Pterygoid Guided Drill Ø2.7/3.4 x 12mm Lg FDA UDI

Identifiers

Primary DI / UDI-DI: 00810060225752 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Fixture/appliance dental drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fixture/appliance dental drill bit, reusable

Blue Sky Bio, LLC. by Blue Sky Bio Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Blue Sky Bio Llc

Sources (1)

FDA UDI f4ffb182-041c-4823-8293-b4fceac85905 33 fields · synced May 31, 2026