FDA UDI In Commercial Distribution 🇺🇸 United States

C.I.™

DI: 10810000526236 · Model: S094 · PARKELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20

Basic Information

Brand Name
C.I.™
Primary DI
10810000526236
Version / Model
S094
Catalog Number
S094
Company Name
PARKELL, INC.
Labeler DUNS
009900424
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2019-04-05
Public Version
2
Public Version Date
2023-12-21
Public Version Status
Update
Public Device Record Key
10cce3ee-32a9-4af2-8f55-2d9c330b4b8e

Device Description

Medium C.I.™ White Fiber Post Refills (Pkg. of 20 Posts)

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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
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

Product Codes

Code Name
ELR Post, Root Canal

GMDN Terms

Code Name
38609 Root canal post, preformed

Identifiers

Type ID
Primary 10810000526236
Unit of Use 00810000526239

Customer Contacts

Phone
631-249-1134