Identity
- Trade Name
- Disposable Instruments FDA UDI
- Generic Name
- Ophthalmic working-channel cannula, single-use FDA UDI
- Device Name
- Cortical Cleaving Hydrodissector 27g x 7/8” (0.4 x 22mm),11mm Bend, Round End, Bulk, Non-Sterile FDA UDI
- Model / Reference
- B-4036P-NSC FDA UDI
- Description
- Cortical Cleaving Hydrodissector 27g x 7/8” (0.4 x 22mm),11mm Bend, Round End, Bulk, Non-Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10845819005955 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic working-channel cannula, 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
No
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
Yes
FDA UDI
Category: Ophthalmic working-channel cannula, single-use
Cortical Cleaving Hydrodissector 27g x 7/8” (0.4 x 22mm),11mm Bend, Round End, Bulk, Non-Sterile - A disposable instrument designed for creating a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery.
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Also classified as Ophthalmic working-channel cannula, single-use.
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- Disposable Instruments — OASIS Medical, Inc. · Class I
- Disposable Instruments — OASIS Medical, Inc. · Class I
- Disposable Instruments — OASIS Medical, Inc. · Class I
- Disposable Instruments — OASIS Medical, Inc. · Class I
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
- OASIS Medical, Inc.
Sources (1)
- FDA UDI 1a7d1260-02e4-4181-a275-d837d17c6b74 34 fields · synced Jul 9, 2026