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Hydroset

FDA UDI

Class I (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
HYDROSET FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
10GAX10CM TEN CANNULAE PACK FDA UDI
Model / Reference
397021 FDA UDI
Description
10GAX10CM TEN CANNULAE PACK FDA UDI

Identifiers

Catalog Number
397021 FDA UDI
Primary DI / UDI-DI
07613154804771 FDA UDI
FDA Product Code
GEA FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 10.0 Centimeter FDA UDI
Needle Gauge — 10.0 Gauge FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial

Hydroset by Stryker Leibinger — Class I — 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 62447c82-8a0d-4834-9b4b-5313f5f375c5 35 fields · synced May 30, 2026