FDA UDI
In Commercial Distribution
🇺🇸 United States
Cordis ExoSeal Vascular Closure Device
DI: 10705032058872
·
Model: EX500
·
CORDIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cordis ExoSeal Vascular Closure Device
- Primary DI
- 10705032058872
- Version / Model
- EX500
- Catalog Number
- EX500
- Company Name
- CORDIS CORPORATION
- Labeler DUNS
- 806136177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-19
- Public Version
- 10
- Public Version Date
- 2022-08-03
- Public Version Status
- Update
- Public Device Record Key
- 4eb4f0d7-524d-4929-8c84-93d567fdc279
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
- MR Conditional
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| MGB | DEVICE, HEMOSTASIS, VASCULAR | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58871 | Femoral artery closure plug/patch, synthetic polymer | An implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of a bioabsorbable synthetic polymer plug and/or patch [e.g., polyglycolic acid (PGA)] that is implanted onto the extravascular (plug-like) and/or intravascular (patch-like) surface of the femoral artery access site. Delivery device(s) dedicated to implant introduction [i.e., not intended to allow access for other devices (catheters)] are typically included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705032058879 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 10705032058872 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged