Identity
- Trade Name
- Merit MAK™ FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Model / Reference
- 00884450012833 FDA UDI
Identifiers
- Catalog Number
- MAK501-PED/A FDA UDI
- Primary DI / UDI-DI
- 00884450012833 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
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
Category: Vascular dilator, single-use
A comprehensive medical device directory featuring the Merit Medical Systems, Inc. MERIT MAK is a single-use, sterilized vessel dilator designed for insertion into blood vessels to unblock, enlarge or measure internal diameter during surgical interventions.
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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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 717687a0-4de3-48fd-b673-7e14a17747fa 34 fields · synced Jul 12, 2026