FDA UDI Not in Commercial Distribution 🇺🇸 United States

Superion Inserter

DI: 00884662000130 · Model: N/A · VERTIFLEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Superion Inserter
Primary DI
00884662000130
Version / Model
N/A
Catalog Number
100-9110
Company Name
VERTIFLEX, INC.
Labeler DUNS
005235436
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-08-16
Public Version
4
Public Version Date
2020-10-05
Public Version Status
Update
Public Device Record Key
ef44ed5e-4ec8-49f0-afd8-95b1d4fb44d7
Distribution End Date
2020-04-17

Device Description

Superion Inserter

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
No
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
Moist Heat or Steam Sterilization

Product Codes

Code Name
NQO Prosthesis, Spinous Process Spacer/Plate

GMDN Terms

Code Name
47127 Lumbar interspinous decompression instrument set, reusable

Identifiers

Type ID
Primary 00884662000130