FDA UDI In Commercial Distribution 🇺🇸 United States

Aarhus Vaginal Template 60, Ø32mm

DI: 00816389028036 · Model: GM11013810 · VARIAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Aarhus Vaginal Template 60, Ø32mm
Primary DI
00816389028036
Version / Model
GM11013810
Catalog Number
GM11013810
Company Name
VARIAN MEDICAL SYSTEMS, INC.
Labeler DUNS
009120817
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-03-31
Public Version
1
Public Version Date
2023-04-10
Public Version Status
New
Public Device Record Key
5421d5be-dec5-4b38-b088-af9b75c8851d

Device Description

Aarhus Vaginal Template 60°, Ø32mm

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Dry Heat Sterilization

Product Codes

Code Name
JAQ System, applicator, radionuclide, remote-controlled

GMDN Terms

Code Name
38409 Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Identifiers

Type ID
Primary 00816389028036

Premarket Submissions

Submission Number Supplement Number
K222775 000