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Hydroset

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
HYDROSET FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
Hydroset Injectable HA Bone Subst. 3cc FDA UDI
Model / Reference
397003 FDA UDI
Description
Hydroset Injectable HA Bone Subst. 3cc FDA UDI

Identifiers

Catalog Number
397003 FDA UDI
Primary DI / UDI-DI
07613154272105 FDA UDI
FDA Product Code
GXP FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5300 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

Yes

FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial

Hydroset by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI dc4a579c-355c-49dc-bbff-778981f8a3b3 35 fields · synced Jun 8, 2026