FDA UDI In Commercial Distribution 🇺🇸 United States

Rumex

DI: 00840159906378 · Model: 6-10/6-0501 · RUMEX INTERNATIONAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Rumex
Primary DI
00840159906378
Version / Model
6-10/6-0501
Catalog Number
6-10/6-0501
Company Name
RUMEX INTERNATIONAL CORP.
Labeler DUNS
041546137
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-02
Public Version
1
Public Version Date
2020-06-10
Public Version Status
New
Public Device Record Key
479f1aec-faa3-4d5c-af3d-46a8754d7e56

Device Description

Side-Port Diamond Knife, 45° Single-Edge Blade, 0.60 mm, Length 110 mm, Straight 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
HNN Knife, Ophthalmic

GMDN Terms

Code Name
32764 Ophthalmic knife, reusable

Identifiers

Type ID
Primary 00840159906378