FDA UDI
In Commercial Distribution
🇺🇸 United States
SafeSheath® Ultra
DI: 30891492002501
·
Model: SU105
·
Oscor Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- SafeSheath® Ultra
- Primary DI
- 30891492002501
- Version / Model
- SU105
- Catalog Number
- SU105
- Company Name
- Oscor Inc.
- Labeler DUNS
- 101835833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-11-27
- Public Version
- 4
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- 44a21219-8b09-47ae-8a2b-abfe9331669a
Device Description
Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F
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 |
|---|---|---|---|---|---|---|
| Primary | 30891492002501 | GS1 | ||||
| Unit of Use | 00891492002500 | GS1 |
Customer Contacts
- Phone
- +1(727)937-2511
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122084 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 18 | Gauge | |
| Device Size Text, specify | Guidewire Length 50 cm | ||
| Device Size Text, specify | Dilator Length 18 cm | ||
| Device Size Text, specify | Sheath Length 13 cm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius