FDA UDI In Commercial Distribution 🇺🇸 United States

TEMPORARY CYLINDER ABUT MULTIFUNCTIONAL

DI: 07899995201096 · Model: PTAM 00 · Sin Sistema de Implante Nacional S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TEMPORARY CYLINDER ABUT MULTIFUNCTIONAL
Primary DI
07899995201096
Version / Model
PTAM 00
Catalog Number
PTAM 00
Company Name
Sin Sistema de Implante Nacional S/A
Labeler DUNS
904569092
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-11
Public Version
1
Public Version Date
2023-07-19
Public Version Status
New
Public Device Record Key
2c6b7e0e-1a9b-4fb0-a479-eb95accb05ca

Device Description

TEMPORARY CYLINDER ABUT MULTIFUNCTIONAL

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
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
NHA Abutment, Implant, Dental, Endosseous

GMDN Terms

Code Name
44880 Dental implant suprastructure, temporary, preformed, single-use

Identifiers

Type ID
Primary 07899995201096

Premarket Submissions

Submission Number Supplement Number
K221453 000