FDA UDI In Commercial Distribution 🇺🇸 United States

CREO

DI: 00889095485042 · Model: 1175.5532 · GLOBUS MEDICAL, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CREO
Primary DI
00889095485042
Version / Model
1175.5532
Company Name
GLOBUS MEDICAL, INC.
Labeler DUNS
139105691
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-06-23
Public Version
1
Public Version Date
2018-07-24
Public Version Status
New
Public Device Record Key
d746c67e-899e-4226-8313-af80fe53e7bd

Device Description

Superior Headed Rod, Full Offset, 5.5, 85mm

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
KWQ Appliance, fixation, spinal intervertebral body
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL

GMDN Terms

Code Name
37272 Trans-facet-screw internal spinal fixation system, sterile

Identifiers

Type ID
Primary 00889095485042

Customer Contacts

Device Sizes

Type Value Unit Text
Outer Diameter 5.5 Millimeter
Length 85 Millimeter