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Stephens Disposable Scissors
FDA 510(k)FDA UDIEUDAMEDClass I (US FDA 510(k))
510(k) K022840Ref S7-1364
Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Intraocular scissors, conventional-hinge, reusable FDA UDI
- Device Name
- Stephens Scissors EUDAMEDFDA UDI
- Model / Reference
- S7-1364 EUDAMEDFDA UDI
- Description
- Stephens Scissors FDA UDI
Identifiers
- Catalog Number
- S7-1364 FDA UDI
- Primary DI / UDI-DI
- 00810799036988 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799036988 EUDAMED
- 510(k) Number
- K022840 FDA 510(k)
- FDA Product Code
- HNF FDA 510(k)FDA UDI
- EMDN Code
- L01040503 IRIS SCISSORS, REUSABLE EUDAMED
- GMDN Term
- Intraocular scissors, conventional-hinge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 886.4350 FDA 510(k)
- Regulation Number
- 886.4350 FDA 510(k)FDA UDI
- Market of Registration
- Norway EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Stephens Disposable Scissors by Stephens Instruments, Inc — Class I — MDD, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K022840 | Class I | Active |
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Manufacturer
- Manufacturer
- Stephens Instruments, Inc
- FDA Applicant
- Stephens Instruments
Sources (3)
- FDA 510(k) K022840 24 fields · synced Jul 9, 2026
- FDA UDI 1db9514f-4eaa-4a66-a10f-e216b6be3995 36 fields · synced May 30, 2026
- EUDAMED 0cebfc88-4089-4a54-b9e7-6b469ef09b1b 61 fields · synced Jul 9, 2026