FDA UDI
In Commercial Distribution
🇺🇸 United States
TS1 Base Kit
DI: 00860009780408
·
Model: TS01-0022
·
Wheelhouse Medical
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TS1 Base Kit
- Primary DI
- 00860009780408
- Version / Model
- TS01-0022
- Catalog Number
- 100-TS1
- Company Name
- Wheelhouse Medical
- Labeler DUNS
- 118496839
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-03
- Public Version
- 1
- Public Version Date
- 2023-08-11
- Public Version Status
- New
- Public Device Record Key
- 1544cfd1-488f-4b68-a512-09921575dd3c
Device Description
The Tube Solutions TS1 BASE KIT is a sterile, single-use, disposable device intended for use during tubular retractor surgery.
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34923 | Suction system catheter, general-purpose | A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009780408 | GS1 |
Customer Contacts
- Phone
- 7049629429
- [email protected]