FDA UDI In Commercial Distribution 🇺🇸 United States

ROOT TIP PICK ELEVATOR

DI: 00192896082281 · Model: 1102-ER1 · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ROOT TIP PICK ELEVATOR
Primary DI
00192896082281
Version / Model
1102-ER1
Catalog Number
1102-ER1
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-21
Public Version
8
Public Version Date
2020-12-04
Public Version Status
Update
Public Device Record Key
ea46ab50-ec03-45e2-b70c-a1cbb084ad91

Device Description

ROOT TIP PICK ELEVATOR HEIDBRINK #1 STRAIGHT SERRATED TIP

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code Name
EMJ ELEVATOR, SURGICAL, DENTAL

GMDN Terms

Code Name
38168 Periosteal elevator, reusable

Identifiers

Type ID
Primary 00192896082281

Customer Contacts