FDA UDI In Commercial Distribution 🇺🇸 United States

Greenwald Surgical Company, Inc.

DI: 10801334010430 · Model: 23800-24 · GRACE MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Greenwald Surgical Company, Inc.
Primary DI
10801334010430
Version / Model
23800-24
Catalog Number
U447D
Company Name
GRACE MANUFACTURING, INC.
Labeler DUNS
607903382
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
7055fe40-c070-4e88-b835-5ff525adf887

Device Description

Collings Knife Electrode

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

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Liquid Chemical"]

Product Codes

Code Name
FAS Electrode, Electrosurgical, Active, Urological

GMDN Terms

Code Name
61876 Open-surgery electrosurgical electrode, monopolar, reusable

Identifiers

Type ID
Primary 10801334010430

Device Sizes

Type Value Unit Text
Device Size Text, specify Sheath size 24 French