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OsteoExpress

FDA UDIEUDAMED

Class II (US FDA UDI)

by Micromedics, Inc.

Identity

Trade Name
OsteoExpress FDA UDI
Generic Name
Bone graft delivery kit FDA UDI
Device Name
Graft Delivery Device, 15 cc, Bulk, Non Sterile, Vented. Quantity is Maximum 25 as customer orders FDA UDI
Model / Reference
GDNS-5215 FDA UDI
Description
Graft Delivery Device, 15 cc, Bulk, Non Sterile, Vented. Quantity is Maximum 25 as customer orders FDA UDI

Identifiers

Primary DI / UDI-DI
90815634020903 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

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

Cleared under the same submission

K151543 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Micromedics, Inc.

Sources (2)

  • FDA UDI 3f64e268-c0d5-4fe8-ae20-0608e7ad27bf 35 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026