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Precautions of Using the Sterilization Cap

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
Precautions of Using the Sterilization Cap FDA UDI
Generic Name
Luminal device flushing tubing set, reusable FDA UDI
Device Name
MAJ-1538 Sterilization Cap FDA UDI
Model / Reference
MAJ-1538 FDA UDI
Description
MAJ-1538 Sterilization Cap FDA UDI

Identifiers

Primary DI / UDI-DI
04953170233012 FDA UDI
510(k) Number
K172726 FDA UDI
FDA Product Code
EOB FDA UDI
NWB FDA UDI
EOQ FDA UDI
GMDN Term
Luminal device flushing tubing set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4760 FDA UDI
876.1500 FDA UDI
874.4680 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Luminal device flushing tubing set, reusable

Precautions of Using the Sterilization Cap by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Luminal device flushing tubing set, reusable.

Cleared under the same submission

K172726 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 25991214-ef11-4aef-87ef-155e7f011ee2 35 fields · synced Jun 6, 2026