Identity
- Trade Name
- Super Sheath FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Model / Reference
- (39086-29B) BT50Z07PGW038 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04543527202206 FDA UDI
- 510(k) Number
- K141070 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Super Sheath by Togo Medikit Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141070 also covers:
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
- Super Sheath — TOGO MEDIKIT CO., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Togo Medikit Co., Ltd.
Sources (1)
- FDA UDI 16e0170c-8d45-4066-b2d5-3531ad1ca74a 34 fields · synced May 30, 2026