FDA UDI In Commercial Distribution 🇺🇸 United States

BUTTON BONDER

DI: D9097000041 · Model: 700-004 · Ortho Arch Company Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BUTTON BONDER
Primary DI
D9097000041
Version / Model
700-004
Catalog Number
700-004
Company Name
Ortho Arch Company Inc
Labeler DUNS
020956330
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-27
Public Version
1
Public Version Date
2023-07-05
Public Version Status
New
Public Device Record Key
e2466552-90a5-4e0c-83da-d67c2abba5ea

Device Description

BUTTON BONDER TIPS AND HANDLE (10 TIPS)

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
EGD Wax, Dental, Intraoral

GMDN Terms

Code Name
42344 Dental mould

Identifiers

Type ID
Primary D9097000041