← Back to catalogue
Disposable frosted scleral depressor
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Disposable frosted scleral depressor FDA UDI
- Generic Name
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
- Device Name
- Disposable frosted scleral depressor. (accessory to D.O.R.C. handheld endoillumination probes) FDA UDI
- Model / Reference
- 2013-033 FDA UDI
- Description
- Disposable frosted scleral depressor. (accessory to D.O.R.C. handheld endoillumination probes) FDA UDI
Identifiers
- Catalog Number
- 2013-033 FDA UDI
- Primary DI / UDI-DI
- 08717872030579 FDA UDI
- 510(k) Number
- K142877 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 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
Disposable frosted scleral depressor by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Ophthalmic fibreoptic light instrument, single-use.
- Synergetics — SYNERGETICS USA, INC. · Class II
- VitreQ — Vitreq B.V. · Class II
- 20ga Curved Laser Probe, Quantel — KATALYST SURGICAL, LLC · Class II
- 27ga Stiff MultiFlex Extendable Laser Probe, Quantel Connector — KATALYST SURGICAL, LLC · Class II
- 27ga Stiff MultiFlex Laser Probe, Alcon Connector — KATALYST SURGICAL, LLC · Class II
- Synergetics — SYNERGETICS USA, INC. · Class II
- VitreQ — Vitreq B.V. · Class II
- Synergetics — SYNERGETICS USA, INC. · Class II
Cleared under the same submission
K142877 also covers:
- 2.4 mm Disposable phaco set with 45° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 2.5 mm Straight phaco needle (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- EVA Custom Vitrectomy Pack VGPC 23G — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- EVA, anterior machine — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- EVA, combined machine — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- EVA, combined machine including Laser (DORC connector) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- EVA, combined machine including Laser (SMA connector) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- I/A Handpiece with curved tip. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- MICS 1.8 mm Triple step angled flared phaco needle. (limited reusable 20x) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Safety filter for Leica Microscopes, Manual — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Safety filter for Leica Microscopes, Passive — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Safety filter for Zeis/Moeller-Wedel Microscopes, Manual — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI fa4443b1-f1b6-402d-a349-11265f2cb58e 35 fields · synced Jun 8, 2026