Model: BRAXM-FP8S
Catalog: BRAXM-FP8S
DI: 08404535024319
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
BRAXM-FP8S FULL PIERCER 8X100MM
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a4cbfcc4-2fe2-4c46-a7aa-839587b2ec13
Distribution Status:
In Commercial Distribution
DUNS Number:
082080136
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08404535024319
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45981
Name: Hard/soft-tissue ultrasonic surgical system
Definition:
An assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and soft tissue, and possibly bone cement during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.
FDA Product Codes
LZV
System, cement removal extraction