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Synthecure

FDA UDI

Class II (US FDA UDI)

by Heraeus Medical LLC

Identity

Trade Name
Synthecure FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Model / Reference
Bone Void Filler Kit, 10cc FDA UDI

Identifiers

Catalog Number
50-010 FDA UDI
Primary DI / UDI-DI
04262531220029 FDA UDI
510(k) Number
K250141 FDA UDI
FDA Product Code
MQV FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial 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

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

Category: Bone matrix implant, synthetic, non-antimicrobial

Synthecure by Heraeus Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, non-antimicrobial.

Cleared under the same submission

K250141 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Heraeus Medical LLC

Sources (1)

  • FDA UDI 67a6142a-930d-4af9-b0d2-47c5e88f7768 34 fields · synced Jun 1, 2026