← Back to catalogue

Balloon Sheath

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
BALLOON SHEATH FDA UDI
Generic Name
Ultrasound endoscope balloon, Hevea-latex FDA UDI
Model / Reference
MH-246R FDA UDI

Identifiers

Catalog Number
N5377831 FDA UDI
Primary DI / UDI-DI
04953170463501 FDA UDI
510(k) Number
K961048 FDA UDI
FDA Product Code
FED FDA UDI
ODG FDA UDI
GMDN Term
Ultrasound endoscope balloon, Hevea-latex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

No

FDA UDI

Category: Ultrasound endoscope balloon, Hevea-latex

Balloon Sheath by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound endoscope balloon, Hevea-latex.

Cleared under the same submission

K961048 also covers:

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
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 5b9a1e80-3fd7-4c3d-b713-444c4590fcc9 35 fields · synced Jun 8, 2026