FDA UDI In Commercial Distribution 🇺🇸 United States

ProLift Lateral

DI: 00190837090821 · Model: 114-571-1 · Life Spine, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ProLift Lateral
Primary DI
00190837090821
Version / Model
114-571-1
Catalog Number
114-571-1
Company Name
Life Spine, Inc.
Labeler DUNS
183641617
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-11-07
Public Version
2
Public Version Date
2020-02-24
Public Version Status
Update
Public Device Record Key
d4879978-5229-4810-9519-5406c1cc60b3

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
MAX Intervertebral fusion device with bone graft, lumbar

GMDN Terms

Code Name
38161 Metallic spinal interbody fusion cage

Identifiers

Type ID
Primary 00190837090821

Premarket Submissions

Submission Number Supplement Number
K191005 000