FDA UDI In Commercial Distribution 🇺🇸 United States

Inion® Universal instruments

DI: 06438408002014 · Model: 1 · Inion Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Inion® Universal instruments
Primary DI
06438408002014
Version / Model
1
Catalog Number
INS-9044
Company Name
Inion Oy
Labeler DUNS
367994657
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-08
Public Version
1
Public Version Date
2020-05-18
Public Version Status
New
Public Device Record Key
82ce047a-113a-44a1-8173-377f544cb16e

Device Description

Trocar

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
Yes
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
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

GMDN Terms

Code Name
13380 Hand-held dental retractor

Identifiers

Type ID
Secondary M224INS90449
Primary 06438408002014