FDA UDI In Commercial Distribution 🇺🇸 United States

ORTHOMETRIC ELASTOMERICS - INTRA ORAL

DI: 07908470701997 · Model: 60.01.1004 · ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ORTHOMETRIC ELASTOMERICS - INTRA ORAL
Primary DI
07908470701997
Version / Model
60.01.1004
Catalog Number
60.01.1004
Company Name
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Labeler DUNS
898330003
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-28
Public Version
1
Public Version Date
2022-10-06
Public Version Status
New
Public Device Record Key
8fd4c1aa-73b8-4ae4-ac5a-9bf188f1f23d

Device Description

ORTHODONTIC ELASTIC- LATEX- INTRA-ORAL- LIGHT 5/16

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ECI Band, Elastic, Orthodontic

GMDN Terms

Code Name
62074 Orthodontic inter-arch elastic band

Identifiers

Type ID
Primary 07908470701997