FDA UDI In Commercial Distribution 🇺🇸 United States

Ring Nut Loading Base

DI: 07290115932485 · Model: 88668 · PREMIA SPINE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Ring Nut Loading Base
Primary DI
07290115932485
Version / Model
88668
Company Name
PREMIA SPINE LTD
Labeler DUNS
649220779
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-10-01
Public Version
1
Public Version Date
2024-10-09
Public Version Status
New
Public Device Record Key
37bd4323-ccf1-4bd7-a5ff-bb74902f68b7

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
Yes
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
NKB Thoracolumbosacral Pedicle Screw System

GMDN Terms

Code Name
61929 Orthopaedic implant aiming/guiding block attachment tool

Identifiers

Type ID
Primary 07290115932485

Premarket Submissions

Submission Number Supplement Number
K232719 000