Identity
- Trade Name
- PMT® CORPORATION FDA UDI
- Generic Name
- Subcutaneous tunneller, single-use FDA UDI
- Device Name
- LEUTHARDT GRID HOLE PUNCH FDA UDI
- Model / Reference
- 2105-9 FDA UDI
- Description
- LEUTHARDT GRID HOLE PUNCH FDA UDI
Identifiers
- Catalog Number
- 2105-9 FDA UDI
- Primary DI / UDI-DI
- 00650551098423 FDA UDI
- FDA Product Code
- HAO FDA UDI
- GMDN Term
- Subcutaneous tunneller, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4535 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
No
FDA UDI
Hydrogen Peroxide FDA UDI
Category: Subcutaneous tunneller, single-use
Pmt® Corporation by Pmt Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mainstay Tunneler — MAINSTAY MEDICAL LIMITED · Class III
- Argyle — Mozarc Medical US 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 I | Pending data |
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Manufacturer
- Manufacturer
- Pmt Corp.
Sources (1)
- FDA UDI 00b0a0a9-6f20-4834-b321-4ee80b702ff8 35 fields · synced Jun 8, 2026