Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Eye muscle hook, reusable FDA UDI
- Device Name
- Bowman Lacrimal Probe Set of 6, Sterling FDA UDI
- Model / Reference
- SD934117101 FDA UDI
- Description
- Bowman Lacrimal Probe Set of 6, Sterling FDA UDI
Identifiers
- Catalog Number
- SD934117101 FDA UDI
- Primary DI / UDI-DI
- B382SD9341171010 FDA UDI
- FDA Product Code
- FGN FDA UDI
- GMDN Term
- Eye muscle hook, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Eye muscle hook, reusable
Surgical Direct's Eye muscle hook, a reusable surgical instrument designed for strabismus correction surgery. Made with high-quality materials and engineered for precision and reliability, this hand-held manual device is ideal for locating and hooking extraocular muscles. Sterilization methods include Moist Heat or Steam Sterilization, ensuring the highest level of safety and efficacy.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 8a28d81a-1d4e-413f-b01b-804d6e4eafa3 35 fields · synced Jul 21, 2026