Identity
- Trade Name
- Single Spike Infiltration Tubing - ReShape FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- KLEIN INFILTRATION SET FDA UDI
- Model / Reference
- ITS-10-RS FDA UDI
- Description
- KLEIN INFILTRATION SET FDA UDI
Identifiers
- Catalog Number
- ITS-10-RS FDA UDI
- Primary DI / UDI-DI
- 30816989020103 FDA UDI
- FDA Product Code
- KGZ FDA UDI
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Single Spike Infiltration Tubing - ReShape by Hk Surgical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Hk Surgical Inc.
Sources (1)
- FDA UDI d31a5ce6-b30e-4abe-9cd9-ee372d7ec070 36 fields · synced May 30, 2026