FDA UDI In Commercial Distribution 🇺🇸 United States

Gyrus ACMI

DI: 00821925035867 · Model: PK-CF0533 · Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Gyrus ACMI
Primary DI
00821925035867
Version / Model
PK-CF0533
Company Name
Gyrus Acmi, Inc.
Labeler DUNS
007198742
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-05
Public Version
7
Public Version Date
2023-10-03
Public Version Status
Update
Public Device Record Key
73dccc2d-779d-4291-9b7d-1f28d0dc0535

Device Description

PK CUTTING FORCEPS, 5 mm, 33 cm

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
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
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

GMDN Terms

Code Name
44776 Electrosurgical system

Identifiers

Type ID
Package 00821925035850
Primary 00821925035867