20GA Tapered Diffusion Light Pipe - 287 Connector
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 20GA TAPERED DIFFUSION LIGHT PIPE EUDAMED20GA Tapered Diffusion Light Pipe - 287 Connector FDA UDI20GA Tapered Diffusion Light Pipe - DORC FDA UDI
- Generic Name
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
- Device Name
- 20GA TAPERED DIFFUSION LIGHT PIPE EUDAMED20GA Tapered Diffusion Light Pipe - 287 Connector FDA UDI20GA Tapered Diffusion Light Pipe - DORC FDA UDI
- Model / Reference
- PD104.14 EUDAMEDFDA UDIPD101.14 FDA UDI
- Description
- 20GA Tapered Diffusion Light Pipe - 287 Connector FDA UDI20GA Tapered Diffusion Light Pipe - DORC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10632307001304 EUDAMED00632307001154 FDA UDI00632307001307 FDA UDI
- Basic UDI-DI
- B-10632307001304 EUDAMED
- 510(k) Number
- K980025 FDA UDI
- FDA Product Code
- MPA FDA UDI
- EMDN Code
- Q021108 OPHTHALMIC SURGERY PROBES, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Needle Gauge — 20 Gauge FDA UDI
Category: Ophthalmic fibreoptic light instrument, single-use
20GA Tapered Diffusion Light Pipe - 287 Connector by Peregrine Surgical, LLC. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K980025 also covers:
- 20GA Tapered Diffusion Light Pipe - 297 Connector — Peregrine Surgical, LLC.
- 20GA Tapered Diffusion Light Pipe - Standard — Peregrine Surgical, LLC.
- 20GA Tapered Diffusion Light Pipe - Universal (Large) — Peregrine Surgical, LLC.
- 23GA Wide Angle Light Pipe - Universal — Peregrine Surgical, LLC.
- 25GA Wide Angle Light Pipe - Universal — Peregrine Surgical, LLC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Peregrine Surgical, LLC.
Sources (3)
- FDA UDI 36169808-ec31-4fd3-b7f4-73fa6bb67614 36 fields · synced Jul 8, 2026
- FDA UDI 87e486fb-f519-4a86-8f09-0e6d7044ee4d 36 fields · synced May 30, 2026
- EUDAMED fad33d18-1ae8-4cdd-b14f-f1f2ff8b45cf 61 fields · synced Jul 8, 2026