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BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm
FDA UDIClass II (US FDA UDI)
by Promepla
Identity
- Trade Name
- BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm FDA UDI
- Generic Name
- Ureteral catheter FDA UDI
- Model / Reference
- ROUS1245ST FDA UDI
Identifiers
- Catalog Number
- ROUS1245ST FDA UDI
- Primary DI / UDI-DI
- 03700512963615 FDA UDI
- 510(k) Number
- K140441 FDA UDI
- FDA Product Code
- KNY FDA UDI
- GMDN Term
- Ureteral catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
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: Ureteral catheter
BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm by Promepla — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral catheter.
- Bard® Polyurethane Ureteral Catheters, Open Tip — C. R. Bard, Inc. · Class II
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Bard® Woven Ureteral Catheter — C. R. Bard, Inc. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Coloplast — Coloplast A/S · Class II
- UroForce® Balloon Dilation Catheter — C. R. Bard, Inc. · Class II
- Metal Catheter — RZ-Medizintechnik GmbH · Class I
Cleared under the same submission
K140441 also covers:
- BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cm — Promepla
- BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cm — Promepla
- Bi-Flex — Promepla
- RocaFlex Access Sheath & Dilation Catheter 10/12x35cm — Promepla
- RocaFlex Access Sheath & Dilation Catheter 10/12x45cm — Promepla
- RocaFlex Access Sheath & Dilation Catheter 12/14x35cm — Promepla
- RocaFlex Access Sheath & Dilation Catheter 12/14x45cm — Promepla
- Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm — Promepla
- Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm — Promepla
- Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm — Promepla
- Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm — Promepla
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
- Promepla
Sources (1)
- FDA UDI 9a6194c9-d308-4b7d-9033-a37fd8a2f6e4 35 fields · synced May 30, 2026