FDA UDI In Commercial Distribution 🇺🇸 United States

PERLA ® TL MIS

DI: 07640450863249 · Model: MPF-IN 24 01-N · SpineArt SA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PERLA ® TL MIS
Primary DI
07640450863249
Version / Model
MPF-IN 24 01-N
Catalog Number
MPF-IN 24 01-N
Company Name
SpineArt SA
Labeler DUNS
483016148
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-02-08
Public Version
1
Public Version Date
2021-02-16
Public Version Status
New
Public Device Record Key
7cfdbab2-e995-4226-aa7d-8cb9e746c1f9

Device Description

CALIPER - ARM 2

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
Yes
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
KWP Appliance, Fixation, Spinal Interlaminal
NKB Thoracolumbosacral Pedicle Screw System

GMDN Terms

Code Name
32845 Surgical depth gauge, reusable

Identifiers

Type ID
Primary 07640450863249