Identity
- Trade Name
- Penlight FDA UDI
- Generic Name
- Corneal marker handpiece FDA UDI
- Device Name
- Soft LED Pupil Gauge Penlight FDA UDI
- Model / Reference
- S214-AQS FDA UDI
- Description
- Soft LED Pupil Gauge Penlight FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00786511247942 FDA UDI
- FDA Product Code
- KYT FDA UDI
- GMDN Term
- Corneal marker handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Corneal marker handpiece
Penlight by Rashman Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Corneal marker handpiece.
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- Penlight — Rashman Corp. · Class I
- Penlight — Rashman Corp. · Class I
- Penlight — Rashman Corp. · Class I
- Penlight — Rashman Corp. · Class I
- Penlight — Rashman Corp. · Class I
- Penlight — Rashman Corp. · Class I
- Penlight — Rashman Corp. · 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
- Rashman Corp.
Sources (1)
- FDA UDI 983777cf-5c60-427f-ae26-28266ae899b7 33 fields · synced Jun 8, 2026