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SpyGlass DS

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
SpyGlass DS FDA UDI
Generic Name
Endoscopic video image processing/light source system FDA UDI
Device Name
Digital Controller FDA UDI
Model / Reference
M0054665R0 FDA UDI
Description
Digital Controller FDA UDI

Identifiers

Primary DI / UDI-DI
08714729874362 FDA UDI
FDA Product Code
FBN FDA UDI
KQM FDA UDI
NTN FDA UDI
GMDN Term
Endoscopic video image processing/light source system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
878.4160 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic video image processing/light source system

SpyGlass DS by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic video image processing/light source system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI b106c23f-ba91-4f42-94c1-3dc74362987b 33 fields · synced May 30, 2026