FDA UDI Not in Commercial Distribution 🇺🇸 United States

Integra® Miltex®

DI: 10381780497844 · Model: 700510-7000-001 · INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250

Basic Information

Brand Name
Integra® Miltex®
Primary DI
10381780497844
Version / Model
700510-7000-001
Catalog Number
700510-7000-001
Company Name
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Labeler DUNS
081277700
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
250
Record Status
Published
Publish Date
2018-10-24
Public Version
3
Public Version Date
2022-07-19
Public Version Status
Update
Public Device Record Key
3eb09ce7-1e3b-44c6-ba59-181554656be5
Distribution End Date
2022-05-01

Device Description

True Stop Endo Stop Dispenser - Silicone, Rust, Package of 250

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
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

Product Codes

Code Name
EKS FILE, PULP CANAL, ENDODONTIC

GMDN Terms

Code Name
45123 Endodontic stopper

Identifiers

Type ID
Secondary H83470051070000011
Primary 10381780497844
Unit of Use 00381780497847

Customer Contacts