FDA UDI Not in Commercial Distribution 🇺🇸 United States

Integra® Jarit®

DI: 10381780171843 · Model: 310-380 · INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Integra® Jarit®
Primary DI
10381780171843
Version / Model
310-380
Company Name
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Labeler DUNS
081277700
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-23
Public Version
7
Public Version Date
2020-07-07
Public Version Status
Update
Public Device Record Key
9482d38e-6562-4566-977c-ad478260c037
Distribution End Date
2018-07-10

Device Description

DIETHRICH BYPASS KIT

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
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
DQR CANNULA, CATHETER

GMDN Terms

Code Name
47132 Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial

Identifiers

Type ID
Secondary M2743103801
Primary 10381780171843

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K131446 000