FDA UDI
In Commercial Distribution
🇺🇸 United States
SafeSheath® II
DI: 10885672009882
·
Model: SSC9
·
Oscor Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- SafeSheath® II
- Primary DI
- 10885672009882
- Version / Model
- SSC9
- Catalog Number
- SSC9
- Company Name
- Oscor Inc.
- Labeler DUNS
- 101835833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-08-06
- Public Version
- 1
- Public Version Date
- 2020-08-14
- Public Version Status
- New
- Public Device Record Key
- a636fd8a-c62e-4235-b579-a19c915679a0
Device Description
Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
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
- 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 |
|---|---|---|---|---|
| DYB | INTRODUCER, CATHETER | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00885672009885 | GS1 | ||||
| Primary | 10885672009882 | GS1 |
Customer Contacts
- Phone
- +1(727)937-2511
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122084 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Sheath Length 15.32 cm | ||
| Lumen/Inner Diameter | 3 | Millimeter | |
| Device Size Text, specify | Syringe 10 cc |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius