FDA UDI In Commercial Distribution 🇺🇸 United States

Cirq Robotic Alignment Module

DI: 04056481141646 · Model: 56100 · Brainlab AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Cirq Robotic Alignment Module
Primary DI
04056481141646
Version / Model
56100
Catalog Number
56100
Company Name
Brainlab AG
Labeler DUNS
314482980
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-01-04
Public Version
5
Public Version Date
2023-09-20
Public Version Status
Update
Public Device Record Key
73ec2839-1bc0-44a0-8e3f-2f3aaef83c4f

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HAW Neurological Stereotaxic Instrument
OLO Orthopedic Stereotaxic Instrument

GMDN Terms

Code Name
62380 Surgical instrument assist arm system, power-adjusted

Identifiers

Type ID
Primary 04056481141646

Premarket Submissions

Submission Number Supplement Number
K202320 000
K210989 000
K221618 000
K223864 000