Identity
- Trade Name
- PMT CORPORATION - STEREOTACTIC FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- REDUCING TUBE FOR 3.2MM DRILL - NEUROMATE FDA UDI
- Model / Reference
- 2103-195 FDA UDI
- Description
- REDUCING TUBE FOR 3.2MM DRILL - NEUROMATE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650551147008 FDA UDI
- 510(k) Number
- K831329 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hydrogen Peroxide FDA UDI
Category: Neurological stereotactic surgery system
Pmt Corporation - Stereotactic by Pmt Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K831329 also covers:
- ACCUNAV® — Pmt Corp.
- PMT CORPORATION — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
- PMT CORPORATION - STEREOTACTIC — Pmt Corp.
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
- Pmt Corp.
Sources (1)
- FDA UDI c6ba154d-d7a6-49e5-a15a-1ab0a0e4960d 34 fields · synced May 31, 2026