← Back to catalogue

Aquari Surf Back Skytron 3501b

FDA UDI

Class II (US FDA UDI)

by Mizuho Orthopedic Systems, Inc.

Identity

Trade Name
AQUARI SURF BACK SKYTRON 3501B FDA UDI
Generic Name
Operating table patient pressure distribution monitoring/regulation system FDA UDI
Model / Reference
246-B3502 FDA UDI

Identifiers

Catalog Number
246-B3502 FDA UDI
Primary DI / UDI-DI
00842430115530 FDA UDI
FDA Product Code
FNM FDA UDI
GMDN Term
Operating table patient pressure distribution monitoring/regulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating table patient pressure distribution monitoring/regulation system

Aquari Surf Back Skytron 3501b by Mizuho Orthopedic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table patient pressure distribution monitoring/regulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Mizuho Orthopedic Systems, Inc.

Sources (1)

  • FDA UDI c6c25efe-dcf1-439a-a160-f51f68aac529 35 fields · synced Jun 9, 2026