FDA UDI In Commercial Distribution 🇺🇸 United States

High Heat Height Gauge

DI: 00190730011596 · Model: OT-2118-HH · ORTHO TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
High Heat Height Gauge
Primary DI
00190730011596
Version / Model
OT-2118-HH
Company Name
ORTHO TECHNOLOGY, INC.
Labeler DUNS
781772017
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-05-02
Public Version
2
Public Version Date
2019-08-09
Public Version Status
Update
Public Device Record Key
0b2e285a-3695-4835-9ff6-b28b34faca3b

Device Description

Bracket Height Gauge High Heat 018

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EIL GAUGE, DEPTH, INSTRUMENT, DENTAL

GMDN Terms

Code Name
31799 Orthodontic appliance dimension gauge

Identifiers

Type ID
Primary 00190730011596