Identity
- Trade Name
- JULIET ® LL FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- LATERAL RASP TRIAL 17MM H12 FDA UDI
- Model / Reference
- SPE-US 00 83-N FDA UDI
- Description
- LATERAL RASP TRIAL 17MM H12 FDA UDI
Identifiers
- Catalog Number
- SPE-US 00 83-N FDA UDI
- Primary DI / UDI-DI
- 07640450865526 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Yes
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
Dimensions & Sizes
- Size
- Length — 17 Millimeter FDA UDIHeight — 12 Millimeter FDA UDI
Category: Surgical depth gauge, reusable
Juliet ® Ll by Spineart — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical depth gauge, reusable.
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- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · 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
- Spineart
Sources (1)
- FDA UDI c08dbed9-1342-41af-92d4-bf69ec9bb2a0 35 fields · synced Jun 1, 2026