FDA UDI In Commercial Distribution 🇺🇸 United States

Obtura Spartan

DI: 00816168020558 · Model: 930-050 · OBTURA SPARTAN ENDODONTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Obtura Spartan
Primary DI
00816168020558
Version / Model
930-050
Catalog Number
930-050
Company Name
OBTURA SPARTAN ENDODONTICS
Labeler DUNS
078371330
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-03
Public Version
3
Public Version Date
2022-09-27
Public Version Status
Update
Public Device Record Key
35fba2ad-1b33-4ba9-8689-ccad4117f55c

Device Description

Tip Set of 6 BUC Access Contains: 930-041 Tip BUC-1 DI# 00816168020299 930-042 Tip BUC-2 DI# 00816168020305 930-043 Tip BUC-3 DI# 00816168020312 930-046 Tip BUC-2A DI# 00816168020510 930-048 Tip BUC-1A DI# 00816168020534 930-049 Tip BUC-3A DI# 00816168020541

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
PM Exempt
No
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
ELC Scaler, Ultrasonic

GMDN Terms

Code Name
44908 Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Identifiers

Type ID
Primary 00816168020558