Identity
- Trade Name
- CEREGLIDE FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- CEREGLIDE 92 Catheter System CEREGLIDE 92 INNERGLIDE 9 130 cm 165 cm 0.092 in (2.34 mm) 0.030 in (0.76 mm) 0.102 in (2.59 mm) 0.042 in (1.07 mm) 0.108 in (2.74 mm) 0.078 in (1.98 mm) 0.113 in (2.87 mm) Minimum Guide Diameter FDA UDI
- Model / Reference
- SBC92130UG FDA UDI
- Description
- CEREGLIDE 92 Catheter System CEREGLIDE 92 INNERGLIDE 9 130 cm 165 cm 0.092 in (2.34 mm) 0.030 in (0.76 mm) 0.102 in (2.59 mm) 0.042 in (1.07 mm) 0.108 in (2.74 mm) 0.078 in (1.98 mm) 0.113 in (2.87 mm) Minimum Guide Diameter FDA UDI
Identifiers
- Catalog Number
- SBC92130UG FDA UDI
- Primary DI / UDI-DI
- 10886704086079 FDA UDI
- 510(k) Number
- K230726 FDA UDI
- FDA Product Code
- QJP FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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: Vascular guide-catheter, single-use
Cereglide by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230726 also covers:
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
- Cerenovus, Inc.
Sources (1)
- FDA UDI 950378a5-dff3-4d11-8e27-e6c6c5149f4c 36 fields · synced May 30, 2026