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Osteoxpress

FDA UDI

Class II (US FDA UDI)

by Micromedics, Inc.

Identity

Trade Name
OSTEOXPRESS FDA UDI
Generic Name
Bone graft delivery kit FDA UDI
Device Name
GRAFT DELIVERY DEVICE - Molded Tray in Pouch FDA UDI
Model / Reference
GD-5515 FDA UDI
Description
GRAFT DELIVERY DEVICE - Molded Tray in Pouch FDA UDI

Identifiers

Primary DI / UDI-DI
00815634020467 FDA UDI
510(k) Number
K151543 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
Bone graft delivery kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K151543 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micromedics, Inc.

Sources (1)

  • FDA UDI e04212db-db40-42fb-883b-f05296bd9c5e 35 fields · synced May 30, 2026