FDA UDI In Commercial Distribution 🇺🇸 United States

Atlas Choice Microsurgery Pattie Collection

DI: 00749915002937 · Model: 301-01 · AMERICAN SURGICAL COMPANY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Atlas Choice Microsurgery Pattie Collection
Primary DI
00749915002937
Version / Model
301-01
Company Name
AMERICAN SURGICAL COMPANY, LLC
Labeler DUNS
151054954
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-12-09
Public Version
1
Public Version Date
2021-12-17
Public Version Status
New
Public Device Record Key
36e34e36-51bc-44ff-aa74-f3bbaae86a55

Device Description

Atlas Choice Microsurgery Pattie Collection

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HBA Neurosurgical Paddie

GMDN Terms

Code Name
13702 Neurosurgical sponge

Identifiers

Type ID
Primary 00749915002937

Premarket Submissions

Submission Number Supplement Number
K902921 000
K904514 000