FDA UDI In Commercial Distribution 🇺🇸 United States

AOS Rectal Template, Syed/Neblett

DI: 00850645007496 · Model: TRD0001-017 · ALPHA-OMEGA SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AOS Rectal Template, Syed/Neblett
Primary DI
00850645007496
Version / Model
TRD0001-017
Company Name
ALPHA-OMEGA SERVICES, INC.
Labeler DUNS
060398989
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-04
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
4b3a664d-e881-4243-9bb1-e4de032c57f8

Device Description

Template, Syed/Neblett/Hedger, Series-17, Rectal, (36 Holes), Blue, 1 ea

Device Characteristics

Single Use
Yes
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
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code Name
JAQ System, Applicator, Radionuclide, Remote-Controlled

GMDN Terms

Code Name
38431 Anorectal brachytherapy system applicator, remote-afterloading

Identifiers

Type ID
Primary 00850645007496