FDA UDI In Commercial Distribution 🇺🇸 United States

Integra® Jarit®

DI: 10381780194934 · Model: 350098 · INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Integra® Jarit®
Primary DI
10381780194934
Version / Model
350098
Catalog Number
350-098
Company Name
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Labeler DUNS
081277700
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-10-31
Public Version
5
Public Version Date
2023-04-20
Public Version Status
Update
Public Device Record Key
82dfeb60-1263-486f-886b-80fafb21551a

Device Description

Integra® Jarit® Alfonso Eye Speculum, 1-7/8", Open Blades, Infant, 5mm Blade, 28mm Spread

Device Characteristics

Single Use
No
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
HNC Specula, ophthalmic

GMDN Terms

Code Name
35349 Eyelid speculum, reusable

Identifiers

Type ID
Secondary M2743500981
Primary 10381780194934

Customer Contacts