Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Model / Reference
- 00884450015292 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450015292 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Vascular dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular dilator, single-use
A comprehensive medical device directory listing the Merit Medical vascular dilator, a sterile hand-held instrument for insertion into blood vessels to unblock or enlarge their diameter during surgical interventions.
Similar devices
Also classified as Vascular dilator, single-use.
- MICRO-STICK SET — JET MEDICAL, INC. · Class II
- TightRail™ — Spectranetics Corporation · Class II
- MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR — MEDICAL COMPONENTS INC · Class II
- MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR — MEDICAL COMPONENTS INC · Class II
- SJM™ — ST. JUDE MEDICAL, INC. · Class II
- MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR — MEDICAL COMPONENTS INC · Class II
- MICRO-STICK SETMICRO-STICK SET — MEDICAL COMPONENTS INC · Class II
- Broadway System — Stryker 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI e9cea8d4-2b08-4efc-8bef-6435bc4b9faa 33 fields · synced Jul 11, 2026