FDA UDI
In Commercial Distribution
🇺🇸 United States
CEREGLIDE
DI: 10886704086048
·
Model: SBC92122UG
·
Cerenovus, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CEREGLIDE
- Primary DI
- 10886704086048
- Version / Model
- SBC92122UG
- Catalog Number
- SBC92122UG
- Company Name
- Cerenovus, Inc.
- Labeler DUNS
- 607846297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-20
- Public Version
- 2
- Public Version Date
- 2026-01-26
- Public Version Status
- Update
- Public Device Record Key
- 1b5fff9c-684a-4e90-bdcd-88212620df45
Device Description
CEREGLIDE 92 Catheter System CEREGLIDE 92 INNERGLIDE 9 122 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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17846 | Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886704086048 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]