FDA UDI In Commercial Distribution 🇺🇸 United States

HALO MOLAR BAND

DI: D9099011001 · Model: U6R PLAIN BAND ASSORTED · Ortho Arch Company Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
HALO MOLAR BAND
Primary DI
D9099011001
Version / Model
U6R PLAIN BAND ASSORTED
Catalog Number
901-100
Company Name
Ortho Arch Company Inc
Labeler DUNS
020956330
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-20
Public Version
1
Public Version Date
2022-10-28
Public Version Status
New
Public Device Record Key
bb1c6d46-0a70-4fe3-8a01-d352fb2dd604

Device Description

U6R PLAIN HALO MOLAR BAND ASSORTED

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
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
No

Product Codes

Code Name
ECI Band, Elastic, Orthodontic

GMDN Terms

Code Name
38734 Orthodontic metal band

Identifiers

Type ID
Primary D9099011001