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Scintillant

FDA UDI

Class I (US FDA UDI)

by BihlerMed, L.L.C.

Identity

Trade Name
Scintillant FDA UDI
Generic Name
Surgical retractor/retraction system blade, reusable FDA UDI
Device Name
Scintillant Surgical Light with Retractor FDA UDI
Model / Reference
2658-01-0004 FDA UDI
Description
Scintillant Surgical Light with Retractor FDA UDI

Identifiers

Primary DI / UDI-DI
10865082000136 FDA UDI
FDA Product Code
GAD FDA UDI
FTD FDA UDI
GMDN Term
Surgical retractor/retraction system blade, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
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

Yes

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: Surgical retractor/retraction system blade, reusableOperating room light

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

Similar devices

Also classified as Operating room light.

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 987aed3e-7eea-44f6-a48b-b1bd99dbffa4 34 fields · synced Jun 8, 2026