Identity
- Trade Name
- 20GA Light Pipe FDA UDI
- Generic Name
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
- Device Name
- 20GA Light Pipe - Universal FDA UDI
- Model / Reference
- PD100.00 FDA UDI
- Description
- 20GA Light Pipe - Universal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00632307000959 FDA UDI
- 510(k) Number
- K980797 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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 20 Gauge FDA UDI
Category: Ophthalmic fibreoptic light instrument, single-use
20GA Light Pipe by Peregrine Surgical, LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 - 287 Connector — Peregrine Surgical, LLC.
- 20GA Light Pipe - 297 Connector — Peregrine Surgical, LLC.
- 20GA Light Pipe - DORC — Peregrine Surgical, LLC.
- 20GA Light Pipe - Standard — Peregrine Surgical, LLC.
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 |
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Manufacturer
- Manufacturer
- Peregrine Surgical, LLC.
Sources (1)
- FDA UDI 417cab9b-2089-4baf-aaca-83f14197dcad 36 fields · synced May 30, 2026