FDA UDI In Commercial Distribution 🇺🇸 United States

Greenwald Surgical Company, Inc.

DI: 10801334004804 · Model: 26502-12 · 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
10801334004804
Version / Model
26502-12
Catalog Number
EET107B
Company Name
GRACE MANUFACTURING, INC.
Labeler DUNS
607903382
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-03-21
Public Version
1
Public Version Date
2022-03-29
Public Version Status
New
Public Device Record Key
3dc2e34c-b8a9-4f0b-aefb-666d9d6deb4d

Device Description

Flexible Endoscopic Electrode, Bugbee Tip

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
No
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
["Moist Heat or Steam Sterilization", "Liquid Chemical", "Ethylene Oxide"]

Product Codes

Code Name
FAS Electrode, Electrosurgical, Active, Urological

GMDN Terms

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

Identifiers

Type ID
Primary 10801334004804

Device Sizes

Type Value Unit Text
Length 60 Centimeter
Device Size Text, specify Shaft size: 2 French