FDA UDI In Commercial Distribution 🇺🇸 United States

SilTrax EPI Retraction Cord 9/1

DI: 00310866000381 · Model: 07210 · PASCAL COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SilTrax EPI Retraction Cord 9/1
Primary DI
00310866000381
Version / Model
07210
Catalog Number
07210
Company Name
PASCAL COMPANY, INC.
Labeler DUNS
009260217
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-01-29
Public Version
1
Public Version Date
2019-03-01
Public Version Status
New
Public Device Record Key
1f2d4f7f-cd79-4040-ab5a-0a48d959e245

Device Description

Braided gingival retraction cord with epinephrine, 72 inches, size 9/1

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
Yes
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
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MVL Cord, Retraction

GMDN Terms

Code Name
46037 Gingival retraction cord, medicated

Identifiers

Type ID
Primary 00310866000381

Customer Contacts

Phone
8004268051

Storage Conditions

Type
Handling Environment Temperature
Temperature Range
59 – 86 Degrees Fahrenheit