Identity
- Trade Name
- Fixation Sticks (4pk) FDA UDI
- Generic Name
- Ophthalmic examination target holder FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B091153020 FDA UDI
- FDA Product Code
- HPL FDA UDI
- GMDN Term
- Ophthalmic examination target holder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1290 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic examination target holder
Fixation Sticks (4pk) by Gulden Ophthalmics — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic examination target holder.
- Flashing Fixation Sticks (2pk) — Gulden Ophthalmics · Class I
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- Peds Pack — Gulden Ophthalmics · Class I
- Flashing Butterfly Fixation Stick — Gulden Ophthalmics · Class I
- Color Fixation Sticks — Gulden Ophthalmics · Class I
- Face Fixation Sticks (3pk) — Gulden Ophthalmics · Class I
- Pediatric Fixation Sticks (3pk) — Gulden Ophthalmics · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gulden Ophthalmics
Sources (2)
- FDA UDI 638dc159-5697-4eb4-839d-8a2491d9a009 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026