FDA UDI In Commercial Distribution 🇺🇸 United States

MCCALL CURETTE

DI: 00192896089440 · Model: 1102-SCMC17-18 · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MCCALL CURETTE
Primary DI
00192896089440
Version / Model
1102-SCMC17-18
Catalog Number
1102-SCMC17-18
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-05-10
Public Version
2
Public Version Date
2019-09-11
Public Version Status
Update
Public Device Record Key
69cd4a59-089d-4ca8-99f6-1abfd725ba39

Device Description

MCCALL CURETTE #17-18 DOUBLE ENDED ELLIPTICAL BLADE ROUND TOE CURVATURE SHANK

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
EMK Curette, Surgical, Dental

GMDN Terms

Code Name
41660 Periodontal curette

Identifiers

Type ID
Primary 00192896089440

Customer Contacts

Phone
800-821-7496

Device Sizes

Type Value Unit Text
Device Size Text, specify 1.2 Millimeter Blades