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Greenlight

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name
GREENLIGHT FDA UDI
Generic Name
Endoscope sheath, reusable FDA UDI
Device Name
OUTER SHEATH LASER THERAPY 21FR color code yellow, SL 221mm, oval, slanted distal end, stainless steel, continuous irrigation, compatible with inner sheath 8632025, and telescopes Ø 4mm, 12°/30°, with 2 flushing ports, E-Line quick connection, reusable FDA UDI
Model / Reference
8632024 FDA UDI
Description
OUTER SHEATH LASER THERAPY 21FR color code yellow, SL 221mm, oval, slanted distal end, stainless steel, continuous irrigation, compatible with inner sheath 8632025, and telescopes Ø 4mm, 12°/30°, with 2 flushing ports, E-Line quick connection, reusable FDA UDI

Identifiers

Catalog Number
8632.024 FDA UDI
Primary DI / UDI-DI
04055207018088 FDA UDI
FDA Product Code
FBO FDA UDI
GMDN Term
Endoscope sheath, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
Not 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 7 Millimeter FDA UDI

Greenlight by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Richard Wolf GmbH

Sources (1)

  • FDA UDI 1a00f5c3-4cc6-4628-8d03-4f53c54e4adc 37 fields · synced May 30, 2026