FDA UDI
In Commercial Distribution
🇺🇸 United States
MoniTorr™ ICP
DI: 10381780072508
·
Model: NL90049S01
·
Integra Lifesciences Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MoniTorr™ ICP
- Primary DI
- 10381780072508
- Version / Model
- NL90049S01
- Catalog Number
- NL90049S01
- Company Name
- Integra Lifesciences Corporation
- Labeler DUNS
- 083171244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-22
- Public Version
- 7
- Public Version Date
- 2023-05-16
- Public Version Status
- Update
- Public Device Record Key
- 3a157850-1c47-4b3d-ad81-be7c824ba4e0
Device Description
Sundt™ One external carotid endarectomy shunt, 30cm non-reinforced segment and a 12cm venting arm with attached luer connector.
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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| DWF | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47113 | Carotid artery shunt | A sterile device designed to serve as a temporary blood conduit (a shunt) connecting the distal internal carotid artery to the proximal common carotid artery allowing intravascular blood to continuously flow to the patient's brain during an endarterectomy procedure. It is typically designed as a hollow shaft with atraumatic dilations (e.g., balloons) on either end. The shaft is inserted into the lumen of the blood vessel, via a small incision at the surgical site. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780072508 | GS1 | ||||
| Secondary | M269NL90049S011 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size: 3mm x 5mm; Distal Tubing: 2mm I.D. x 3mm O.D.; Proximal Tubing: 2mm I.D. x 5mm O.D.; Total Length: 30cm (All dimensions nominal) |