FDA UDI In Commercial Distribution 🇺🇸 United States

CHEWIES™ ALIGNER TRAY SEATERS

DI: 00190707089863 · Model: 617-4505 · ORTHO ORGANIZERS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CHEWIES™ ALIGNER TRAY SEATERS
Primary DI
00190707089863
Version / Model
617-4505
Company Name
ORTHO ORGANIZERS, INC.
Labeler DUNS
062165188
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-17
Public Version
1
Public Version Date
2022-10-25
Public Version Status
New
Public Device Record Key
838e1d64-9d44-4e3b-a08c-0ae49d9d2bdd

Device Description

ALIGNER CHEWIES™ TRAY SEATERS-PINEAPPLE

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ECS PUSHER, BAND, ORTHODONTIC

GMDN Terms

Code Name
31801 Orthodontic metal band pusher

Identifiers

Type ID
Primary 00190707089863