FDA UDI In Commercial Distribution 🇺🇸 United States

GYRUS ACMI

DI: 00821925034846 · Model: 890075 · Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
GYRUS ACMI
Primary DI
00821925034846
Version / Model
890075
Company Name
Gyrus Acmi, Inc.
Labeler DUNS
007198742
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-13
Public Version
2
Public Version Date
2023-08-14
Public Version Status
Update
Public Device Record Key
3107a272-7baa-4259-9d9d-a2007f037936

Device Description

DISPOSABLE SHAH AURAL DRESSING

Device Characteristics

Single Use
Yes
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
Yes
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
NAB Gauze / sponge,nonresorbable for external use

GMDN Terms

Code Name
47783 Patient surgical drape, single-use

Identifiers

Type ID
Package 00821925022966
Primary 00821925034846