FDA UDI In Commercial Distribution 🇺🇸 United States

Guide Wire Ruler

DI: B058ODIT1131 · Model: ODIT113 · Orthopedic Designs North America, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Guide Wire Ruler
Primary DI
B058ODIT1131
Version / Model
ODIT113
Catalog Number
ODI-T113
Company Name
Orthopedic Designs North America, Inc.
Labeler DUNS
945518848
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-13
Public Version
1
Public Version Date
2023-06-21
Public Version Status
New
Public Device Record Key
55d47006-8ac3-4491-a53a-08c558d5bd30

Device Description

Guide Wire Ruler

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
Yes
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
HWT Template

GMDN Terms

Code Name
44796 Medical ruler, reusable

Identifiers

Type ID
Primary B058ODIT1131

Customer Contacts

Phone
888-635-8535