Identity
- Trade Name
- RETRECTOR® FDA UDI
- Generic Name
- Vitrectomy system handpiece tip FDA UDI
- Device Name
- 1 Each Disposable 23 Ga vitrectomy probe with retractable tip for use with the INTRECTOR® Kit during vitreo-retinal surgery FDA UDI
- Model / Reference
- 71005.100 FDA UDI
- Description
- 1 Each Disposable 23 Ga vitrectomy probe with retractable tip for use with the INTRECTOR® Kit during vitreo-retinal surgery FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856222004667 FDA UDI
- FDA Product Code
- HKP FDA UDI
- GMDN Term
- Vitrectomy system handpiece tip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4150 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
Dimensions & Sizes
- Size
- Needle Gauge — 23 Gauge FDA UDI
Category: Vitrectomy system handpiece tip
Retrector® by Insight Instruments, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Insight Instruments, Inc.
Sources (1)
- FDA UDI 4422a790-b4ea-4d7a-ae08-0605b5c4f3a8 35 fields · synced Jun 6, 2026