FDA UDI In Commercial Distribution 🇺🇸 United States

Locking Collets for 16G and 17G needles (pack of 25)

DI: 10816389020174 · Model: GM11012350 · Varian Medical Systems Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25

Basic Information

Brand Name
Locking Collets for 16G and 17G needles (pack of 25)
Primary DI
10816389020174
Version / Model
GM11012350
Catalog Number
GM11012350
Company Name
Varian Medical Systems Deutschland GmbH
Labeler DUNS
332474605
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2017-11-23
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
a069b364-9132-4593-a44d-2e92735d52d5

Device Description

For Kelowna GYN Templates and Crook Prostate Templates

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 Unsafe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code Name
38407 Vaginal brachytherapy system applicator, remote-afterloading

Identifiers

Type ID
Primary 10816389020174
Unit of Use 00816389020177

Premarket Submissions

Submission Number Supplement Number
K162533 000