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Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga FDA UDI
- Generic Name
- Vitrectomy system handpiece tip FDA UDI
- Device Name
- Dispenser Box of 5 Each Sterile Disposable 27 Ga Vitreous Biopsy Probes for use with the INTRECTOR® Kit & 5 Each 10cc Luer Lock Syringes FDA UDI
- Model / Reference
- 71007 FDA UDI
- Description
- Dispenser Box of 5 Each Sterile Disposable 27 Ga Vitreous Biopsy Probes for use with the INTRECTOR® Kit & 5 Each 10cc Luer Lock Syringes FDA UDI
Identifiers
- Catalog Number
- 71007 FDA UDI
- Primary DI / UDI-DI
- 00852475007011 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 — 27 Gauge FDA UDI
Category: Vitrectomy system handpiece tip
Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga 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 a4d44364-1a9a-4992-bda0-cdafa8ea25a8 37 fields · synced Jun 1, 2026