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Pad, Leg Extension

FDA UDIEUDAMED

Class I (US FDA UDI)

by Mizuho Orthopedic Systems, Inc.

Identity

Trade Name
PAD, LEG EXTENSION FDA UDI
Generic Name
Operating table mattress, basic FDA UDI
Device Name
Used with the Mizuho OSI model 6874-515 leg extension board. Made with Tempur-Pedic® Medical materials. FDA UDI
Model / Reference
6844-311 FDA UDI
Description
Used with the Mizuho OSI model 6874-515 leg extension board. Made with Tempur-Pedic® Medical materials. FDA UDI

Identifiers

Catalog Number
6844-311 FDA UDI
Primary DI / UDI-DI
00842430100819 FDA UDI
FDA Product Code
FQO FDA UDI
GMDN Term
Operating table mattress, basic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4960 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 mattress, basic

Pad, Leg Extension by Mizuho Orthopedic Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Operating table mattress, basic.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mizuho Orthopedic Systems, Inc.

Sources (2)

  • FDA UDI e84093d9-3bfc-4c2c-8493-d8bde9ab1d99 36 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026