Identity
- Trade Name
- Black & Black Surgical FDA UDI
- Generic Name
- Urethral sound, reusable FDA UDI
- Device Name
- PRATT UTER DILATOR DE 29-31FR FDA UDI
- Model / Reference
- B95850 FDA UDI
- Description
- PRATT UTER DILATOR DE 29-31FR FDA UDI
Identifiers
- Catalog Number
- B95850 FDA UDI
- Primary DI / UDI-DI
- 00840329829445 FDA UDI
- FDA Product Code
- GCC FDA UDI
- GMDN Term
- Urethral sound, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Urethral sound, reusable
Black & Black Surgical by Black & Black Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urethral sound, reusable.
- Hayden Medical — Hayden Medical Inc · Class I
- KMEDIC — TELEFLEX INCORPORATED · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Hayden Medical — Hayden Medical Inc · Class I
- Sklar® — Sklar Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- Sklar® — Sklar Corporation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Black & Black Surgical, Inc.
Sources (1)
- FDA UDI e78ff634-d2c3-4796-955f-9e762cf0aa06 35 fields · synced May 31, 2026