Identity
- Trade Name
- PERLA ® FDA UDI
- Generic Name
- Surgical instrument handle, torque-limiting FDA UDI
- Device Name
- Straight handle AO Ø17 FDA UDI
- Model / Reference
- HAN-SI AO 17-N FDA UDI
- Description
- Straight handle AO Ø17 FDA UDI
Identifiers
- Catalog Number
- HAN-SI AO 17N FDA UDI
- Primary DI / UDI-DI
- 07640178975101 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Surgical instrument handle, torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument handle, torque-limiting
Perla ® by Spineart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument handle, torque-limiting.
- TLX — Nuvasive, Inc. · Class I
- Tecomet — Tecomet,Inc · Class I
- Tecomet — Tecomet,Inc · Class I
- Tecomet — Tecomet,Inc · Class I
- ReLine — Nuvasive, Inc. · Class I
- InCore MPJ — Medartis Inc. · Class I
- KONG-TL VBR System, Torque Limiter with Coupling, 1/4'' Coupling, 1 Nm — Icotec · Class II
- SI-LUTION Sacroiliac Joint Fusion System — Curiteva, LLC · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineart
Sources (1)
- FDA UDI 76116e77-d2e4-4690-b4d1-e1e58406ffe0 34 fields · synced May 31, 2026