Identity
- Trade Name
- Super Sheath R/O FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Model / Reference
- BT50Z07PPWX38 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04543527267328 FDA UDI
- 510(k) Number
- K200379 FDA UDI
- FDA Product Code
- DRE FDA UDIDYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 FDA UDI870.1340 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
Yes
FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Super Sheath R/O by Togo Medikit Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular catheter introduction set, nonimplantable.
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- ARROW — TELEFLEX INCORPORATED · Class II
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Cleared under the same submission
K200379 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 855cc860-cbb5-4eb8-954a-f95466536462 34 fields · synced Jun 1, 2026