Identity
- Trade Name
- Pedicle Screw Instruments Kit FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Model / Reference
- XM-115-1000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B064XM11510001 FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Bone file/rasp, manual, reusable
Pedicle Screw Instruments Kit by Xenco Medical Llc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Xenco Medical Llc
Sources (1)
- FDA UDI 5571e6de-27a7-474a-bbbf-d86120164db0 32 fields · synced Jun 1, 2026