Identity
- Trade Name
- Bi-Blade® FDA UDI
- Generic Name
- Vitrectomy system micro-cutting unit FDA UDI
- Device Name
- 25 Gauge BB Vitreous Cutter, 20 psi, Luer Anterior PVC Tubing Set, Sterile, Single Use FDA UDI
- Model / Reference
- 2390BB FDA UDI
- Description
- 25 Gauge BB Vitreous Cutter, 20 psi, Luer Anterior PVC Tubing Set, Sterile, Single Use FDA UDI
Identifiers
- Catalog Number
- 2390BB FDA UDI
- Primary DI / UDI-DI
- 00812480011021 FDA UDI
- 510(k) Number
- K153168 FDA UDI
- FDA Product Code
- HQE FDA UDI
- GMDN Term
- Vitrectomy system micro-cutting unit 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDI
Category: Vitrectomy system micro-cutting unit
Bi-Blade® by Medical Instrument Development Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitrectomy system micro-cutting unit.
- Synergetics — SYNERGETICS USA, INC. · Class II
- Oertli® — Oertli-Instrumente AG · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Synergetics — SYNERGETICS USA, INC. · Class II
- Synergetics — SYNERGETICS USA, INC. · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Synergetics — SYNERGETICS USA, INC. · Class II
Cleared under the same submission
K153168 also covers:
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
- Bi-Blade® — Medical Instrument Development Laboratories, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Instrument Development Laboratories, Inc.
Sources (1)
- FDA UDI 610ade5c-b97a-4d33-baba-f964ca987a50 38 fields · synced Jun 8, 2026