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Mira

FDA UDI

Class II (US FDA UDI)

by Virtual Incision

Identity

Trade Name
MIRA FDA UDI
Generic Name
Endoscope sheath, single-use FDA UDI
Model / Reference
180-130000-100 FDA UDI

Identifiers

Catalog Number
MIRA-SUD-NLP FDA UDI
Primary DI / UDI-DI
00850038042097 FDA UDI
510(k) Number
DEN230025 FDA UDI
FDA Product Code
SAB FDA UDI
GMDN Term
Endoscope sheath, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4962 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Endoscope sheath, single-use

Mira by Virtual Incision — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope sheath, single-use.

Cleared under the same submission

DEN230025 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Virtual Incision

Sources (1)

  • FDA UDI e5714da7-9921-4b31-8d54-9676f50e39b4 34 fields · synced May 30, 2026