Identity
- Trade Name
- Fiber Optic Light Guide FDA UDI
- Generic Name
- Intraocular retractor, single-use FDA UDI
- Device Name
- Hardten Iris Retractor Fiber optic light probe with a hooked tip for manipulation and retraction of the iris for optimal visualization of anterior vitreous. 20 ga, with Universal connector. Sterile, single-use. FDA UDI
- Model / Reference
- Iris Retractor, 20 ga FDA UDI
- Description
- Hardten Iris Retractor Fiber optic light probe with a hooked tip for manipulation and retraction of the iris for optimal visualization of anterior vitreous. 20 ga, with Universal connector. Sterile, single-use. FDA UDI
Identifiers
- Catalog Number
- TR9809-11 FDA UDI
- Primary DI / UDI-DI
- 00853480006129 FDA UDI
- FDA Product Code
- HNI FDA UDI
- GMDN Term
- Intraocular retractor, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intraocular retractor, single-use
Fiber Optic Light Guide by Escalon Medical Corp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Escalon Medical Corp
Sources (1)
- FDA UDI 64a51306-669d-49f8-b082-26a68839968f 36 fields · synced Jun 7, 2026