FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ANGIO-SEAL
DI: 00389701011776
·
Model: C610135
·
TERUMO MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ANGIO-SEAL
- Primary DI
- 00389701011776
- Version / Model
- C610135
- Catalog Number
- C610135
- Company Name
- TERUMO MEDICAL CORPORATION
- Labeler DUNS
- 962520628
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-20
- Public Version
- 6
- Public Version Date
- 2023-02-23
- Public Version Status
- Update
- Public Device Record Key
- 103d6868-f623-4f4a-aad3-57add656a07f
- Distribution End Date
- 2022-12-31
Device Description
ANGIO-SEAL EVOLUTION Vascular Closure Device
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 60710 | Femoral artery closure plug/patch, collagen | 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 an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50389701011771 | GS1 | Carton | 2 | Not in Commercial Distribution | 2022-12-31 |
| Package | 30389701011777 | GS1 | Shelfbox | 5 | Not in Commercial Distribution | 2022-12-31 |
| Primary | 00389701011776 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius