Identity
- Trade Name
- Bard® Heyman Follower FDA UDI
- Generic Name
- Urethral dilatation catheter, non-medicated FDA UDI
- Device Name
- Bard® Heyman Follower FDA UDI
- Model / Reference
- 021122 FDA UDI
- Description
- Bard® Heyman Follower FDA UDI
Identifiers
- Catalog Number
- 021122 FDA UDI
- Primary DI / UDI-DI
- 00801741075568 FDA UDI
- FDA Product Code
- FBW FDA UDI
- GMDN Term
- Urethral dilatation catheter, non-medicated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5520 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
Dimensions & Sizes
- Size
- Catheter Gauge — 22 French FDA UDI
Category: Urethral dilatation catheter, non-medicated
Bard® Heyman Follower by C. R. Bard, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urethral dilatation catheter, non-medicated.
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- Optilume BPH Pre-dilation Catheter — Urotronic, Inc. · Class III
- Cook — COOK INCORPORATED · Class I
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
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 275c41cb-3038-4ee9-8da6-0790196bfe10 36 fields · synced Jun 8, 2026