FDA UDI In Commercial Distribution 🇺🇸 United States

Endosee

DI: 60888937026674 · Model: ES-TRAY-IV · Coopersurgical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Endosee
Primary DI
60888937026674
Version / Model
ES-TRAY-IV
Company Name
Coopersurgical, Inc.
Labeler DUNS
801895244
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-02-23
Public Version
3
Public Version Date
2024-02-28
Public Version Status
Update
Public Device Record Key
3d5fcb86-c4d0-498c-a9e3-892859875ef1

Device Description

Endosee System Convenience Kit with IV Tube Instrument Tray for Hysteroscopy

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
FAJ Cystoscope And Accessories, Flexible/Rigid
HIH Hysteroscope (And Accessories)

GMDN Terms

Code Name
37152 Flexible fibreoptic hysteroscope

Identifiers

Type ID
Primary 60888937026674
Package 02088893702667