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Scintillant

FDA UDI

Class II (US FDA UDI)

by BihlerMed, L.L.C.

Identity

Trade Name
Scintillant FDA UDI
Generic Name
Operating room light FDA UDI
Device Name
Scintillant Dual Straight Tip Surgical Light FDA UDI
Model / Reference
2762-01-0004 FDA UDI
Description
Scintillant Dual Straight Tip Surgical Light FDA UDI

Identifiers

Primary DI / UDI-DI
10865082000150 FDA UDI
510(k) Number
K133425 FDA UDI
FDA Product Code
FTD FDA UDI
GMDN Term
Operating room light FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 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

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

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: Operating room light

Scintillant by BihlerMed, L.L.C. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating room light.

Cleared under the same submission

K133425 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BihlerMed, L.L.C.

Sources (1)

  • FDA UDI 22431169-b4d1-4764-b8fc-df80a274dfff 35 fields · synced Jun 1, 2026