Identity
- Trade Name
- Catheter Extender for Yamato Plus IABs - 10 Pack FDA UDI
- Generic Name
- Cardiovascular catheter sheath FDA UDI
- Device Name
- Catheter Extender for Yamato Plus IABs - 10 Pack FDA UDI
- Model / Reference
- 0684-00-0195 FDA UDI
- Description
- Catheter Extender for Yamato Plus IABs - 10 Pack FDA UDI
Identifiers
- Catalog Number
- 0684-00-0195 FDA UDI
- Primary DI / UDI-DI
- 10607567111537 FDA UDI
- FDA Product Code
- DSP FDA UDI
- GMDN Term
- Cardiovascular catheter sheath FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3535 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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 7.5 French FDA UDI
Category: Cardiovascular catheter sheath
Catheter Extender for Yamato Plus IABs - 10 Pack by Datascope Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Datascope Corp.
Sources (1)
- FDA UDI 621db58f-be03-4643-b411-b5f874895b71 36 fields · synced Jun 8, 2026