FDA UDI In Commercial Distribution 🇺🇸 United States

LUXATOR ELEVATOR

DI: 00192896098985 · Model: 1102-LTXS-3S · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LUXATOR ELEVATOR
Primary DI
00192896098985
Version / Model
1102-LTXS-3S
Catalog Number
1102-LTXS-3S
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-09-05
Public Version
4
Public Version Date
2020-12-04
Public Version Status
Update
Public Device Record Key
9b5a713e-94ce-41c0-824a-df47caf64758

Device Description

LUXATOR ELEVATOR STRAIGHT 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
Yes
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 00192896098985

Customer Contacts

Phone
800-821-7496

Device Sizes

Type Value Unit Text
Length 5.75 Inch
Device Size Text, specify 3 Millimeter Tip