FDA UDI In Commercial Distribution 🇺🇸 United States

Rumex

DI: 00840159905623 · Model: 20-013 · RUMEX INTERNATIONAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Rumex
Primary DI
00840159905623
Version / Model
20-013
Catalog Number
20-013
Company Name
RUMEX INTERNATIONAL CORP.
Labeler DUNS
041546137
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-04
Public Version
1
Public Version Date
2020-06-12
Public Version Status
New
Public Device Record Key
f433340e-181d-49d8-9cf5-e69482ce144b

Device Description

LASIK Spatula And Flap Retreatment Instrument, Double-ended, Length 145 mm, Round Titanium Handle

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
["Dry Heat Sterilization", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
HND Spatula, Ophthalmic

GMDN Terms

Code Name
39610 General-purpose surgical spatula

Identifiers

Type ID
Primary 00840159905623