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
34923 Suction system catheter, general-purpose

Identifiers

Type ID
Primary 00860009780408

Customer Contacts

Phone
7049629429