FDA UDI In Commercial Distribution 🇺🇸 United States

Greenwald Surgical Company, Inc.

DI: 10801334003623 · Model: 24660-27 · 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
10801334003623
Version / Model
24660-27
Catalog Number
U247GB
Company Name
GRACE MANUFACTURING, INC.
Labeler DUNS
607903382
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-05
Public Version
3
Public Version Date
2019-02-07
Public Version Status
Update
Public Device Record Key
e35c9940-1cf3-437d-b777-5d855cfd4385

Device Description

STORZ D/S ELECT., GROOVED BLADE

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
["Liquid Chemical", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code Name
FAS Electrode, Electrosurgical, Active, Urological

GMDN Terms

Code Name
61874 Open-surgery electrosurgical electrode, monopolar, single-use

Identifiers

Type ID
Primary 10801334003623

Device Sizes

Type Value Unit Text
Catheter Gauge 27 French