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Shielded TotalView Endoillumination Probe incl illuminated scleral depressor 25G

FDA UDI

Class II (US FDA UDI)

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Identity

Trade Name
Shielded TotalView Endoillumination Probe incl illuminated scleral depressor 25G FDA UDI
Generic Name
Ophthalmic fibreoptic light instrument, single-use FDA UDI
Model / Reference
3269.SBS05 FDA UDI

Identifiers

Catalog Number
3269.SBS05 FDA UDI
Primary DI / UDI-DI
08717872017433 FDA UDI
510(k) Number
K062895 FDA UDI
FDA Product Code
MPA FDA UDI
GMDN Term
Ophthalmic fibreoptic light instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

No

FDA UDI

Category: Ophthalmic fibreoptic light instrument, single-use

Shielded TotalView Endoillumination Probe incl illuminated scleral depressor 25G by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II…

Similar devices

Also classified as Ophthalmic fibreoptic light instrument, single-use.

Cleared under the same submission

K062895 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Sources (1)

  • FDA UDI 050b3707-8555-4d37-847a-ad345738a186 34 fields · synced May 30, 2026