FDA UDI
In Commercial Distribution
🇺🇸 United States
Super Sheath Introducer Sheath
DI: 04543527199759
·
Model: (S-3W5/0897)BT33Z05PGW018
·
TOGO MEDIKIT CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Super Sheath Introducer Sheath
- Primary DI
- 04543527199759
- Version / Model
- (S-3W5/0897)BT33Z05PGW018
- Company Name
- TOGO MEDIKIT CO.,LTD.
- Labeler DUNS
- 690724240
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- e610b0b9-6836-4c92-a542-e47d4500253d
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 14543527199756 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 04543527199759 | GS1 | ||||
| Package | 74543527199758 | GS1 | Carton | 45 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121504 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 18 milli-inch Guidewire | ||
| Device Size Text, specify | 3.3Fr Sheath size | ||
| Device Size Text, specify | 5cm Length |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry, dark, cool place.