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HANA/PROFX TRACTION BOOT XLARGE (pr), REFURBISHED

FDA UDIEUDAMED

Class I (US FDA UDI)

by Mizuho Orthopedic Systems, Inc.

Identity

Trade Name
HANA/PROFX TRACTION BOOT XLARGE (pr), REFURBISHED FDA UDI
Generic Name
Traction boot FDA UDI
Device Name
Left and Right boots FDA UDI
Model / Reference
6850-487R FDA UDI
Description
Left and Right boots FDA UDI

Identifiers

Catalog Number
6850-487R FDA UDI
Primary DI / UDI-DI
00842430103612 FDA UDI
FDA Product Code
JEA FDA UDI
GMDN Term
Traction boot 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: Traction boot

HANA/PROFX TRACTION BOOT XLARGE (pr), REFURBISHED by Mizuho Orthopedic Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Traction boot.

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 af620ef8-9286-45c2-a2ca-f3ef43b627ff 35 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026