Identity
- Trade Name
- Paragon FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Paragon Stem Inserter - Non-Threaded FDA UDI
- Model / Reference
- GM08001-311-00 FDA UDI
- Description
- Paragon Stem Inserter - Non-Threaded FDA UDI
Identifiers
- Catalog Number
- GM08001-311-00 FDA UDI
- Primary DI / UDI-DI
- 09340499024509 FDA UDI
- 510(k) Number
- K123782 FDA UDI
- FDA Product Code
- LZO FDA UDIMEH FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, reusable
Paragon by Global Manufacturing Technology Pty Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
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Cleared under the same submission
K123782 also covers:
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
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 |
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Manufacturer
- Manufacturer
- Global Manufacturing Technology Pty Limited
Sources (1)
- FDA UDI d0453d85-fcb4-4bd2-bbf0-db68431b1270 36 fields · synced May 31, 2026