Identity
- Trade Name
- Merit MAK™ FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Model / Reference
- 00884450144398 FDA UDI
Identifiers
- Catalog Number
- MAK401NEBT/C FDA UDI
- Primary DI / UDI-DI
- 00884450144398 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Vascular dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Vascular dilator, single-use
Merit MAK is a high-quality, single-use, sterile vascular dilator designed for insertion into blood vessels to enlarge or measure the internal diameter during surgical interventions. It features a durable construction, adjustable tip sizes, and is available in various lengths and diameters. The device has been certified by regulatory bodies and meets medical standards for use in various procedures.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 30a8adc0-d90b-4379-9f42-9e4d028c2d2f 34 fields · synced Jul 11, 2026