20GA Side Irrigating Light Pipe
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 20GA Side Irrigating Light Pipe EUDAMEDFDA UDI
- Generic Name
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
- Device Name
- 20GA SIDE IRRIGATING LIGHT PIPE EUDAMED20GA Side Irrigating Light Pipe - Universal FDA UDI
- Model / Reference
- PD100.01 EUDAMEDFDA UDI
- Description
- 20GA Side Irrigating Light Pipe - Universal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10632307000963 EUDAMED00632307000966 FDA UDI
- Basic UDI-DI
- B-10632307000963 EUDAMED
- 510(k) Number
- K980797 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 Side Irrigating Light Pipe by Peregrine Surgical, LLC. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic fibreoptic light instrument, single-use.
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Cleared under the same submission
K980797 also covers:
- 20GA 45 Degree Pick — Peregrine Surgical, LLC.
- 20GA 45 Degree Pick - 287 Connector — Peregrine Surgical, LLC.
- 20GA 45 Degree Pick - 297 Connector — Peregrine Surgical, LLC.
- 20GA Bipolar Manipulator — Peregrine Surgical, LLC.
- 20GA Bipolar Manipulator - 297 Connector — Peregrine Surgical, LLC.
- 20GA Bipolar Manipulator - Standard — Peregrine Surgical, LLC.
- 20GA End Irrigating Light Pipe — Peregrine Surgical, LLC.
- 20GA End Irrigating Light Pipe - 297 Connector — Peregrine Surgical, LLC.
- 20GA Light Pipe — Peregrine Surgical, LLC.
- 20GA Light Pipe - 287 Connector — Peregrine Surgical, LLC.
- 20GA Light Pipe - 297 Connector — Peregrine Surgical, LLC.
- 20GA Light Pipe - DORC — 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 (2)
- FDA UDI cde83dd4-5fb7-4922-a3ee-e75805646857 36 fields · synced Jul 8, 2026
- EUDAMED a339755a-7c51-4827-b974-5c10f1e5bdeb 61 fields · synced Jul 8, 2026