Bio2 Technologies

FDA UDI

Class II (US FDA UDI)

by Bio2 Technologies, Inc.

Identity

Trade Name: Bio2 Technologies FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: VITRIUM E 18 x 5 FDA UDI
Model / Reference: 1000035 FDA UDI
Description: VITRIUM E 18 x 5 FDA UDI

Identifiers

Primary DI / UDI-DI: B01010000351 FDA UDI
510(k) Number: K142463 FDA UDI
K152589 FDA UDI
FDA Product Code: OIS FDA UDI
MQV FDA UDI
GMDN Term: Synthetic bone graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3045 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Synthetic bone graft

Bio2 Technologies by Bio2 Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synthetic bone graft.

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OsseoSculpt Moldable ABG, 3cc — Biogennix, LLC · Class II
Montage Settable Bone Putty — ABYRX, INC. · Class II
IngeniOS HA — curasan AG · Class II
Osbone Dental — curasan AG · Class II
Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II
InQu — Isto Technologies, Inc. · Class II

Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Bio2 Technologies, Inc.

Sources (1)

FDA UDI e469865d-0403-4f2e-bee3-b0ac4bebd564 35 fields · synced May 30, 2026