FDA UDI In Commercial Distribution 🇺🇸 United States

DSS Pedicle Screw Set, Ø5.0 x 60mm

DI: 04260148894282 · Model: DPI55060 · Paradigm Spine GmbH
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DSS Pedicle Screw Set, Ø5.0 x 60mm
Primary DI
04260148894282
Version / Model
DPI55060
Company Name
Paradigm Spine GmbH
Labeler DUNS
537619731
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-03
Public Version
3
Public Version Date
2021-06-10
Public Version Status
Update
Public Device Record Key
ea804ca7-47ab-4e6e-b6bb-13c8023e74ce

Device Characteristics

Single Use
Yes
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
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
NQP Posterior Metal/Polymer Spinal System, Fusion
NKB Thoracolumbosacral Pedicle Screw System
MNI Orthosis, Spinal Pedicle Fixation
MNH Orthosis, Spondylolisthesis Spinal Fixation

GMDN Terms

Code Name
58446 Spinal dynamic-stabilization system

Identifiers

Type ID
Primary 04260148894282