Identity
- Trade Name
- Broadway System FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Model / Reference
- BRW8E105D-3PK01 FDA UDI
Identifiers
- Catalog Number
- BRW8E105D-3PK01 FDA UDI
- Primary DI / UDI-DI
- 07613327639049 FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- 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
Yes
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 catheter introduction set, nonimplantableVascular guide-catheter, single-useVascular dilator, single-use
Broadway System by Stryker Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Merit PAK™ — Merit Medical Systems, Inc. · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 7c06714b-6831-4616-9bb0-b53f391d7859 35 fields · synced May 31, 2026