FDA UDI In Commercial Distribution 🇺🇸 United States

CooperSurgical, Inc.

DI: 00888937011135 · Model: KC-Sizer · Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CooperSurgical, Inc.
Primary DI
00888937011135
Version / Model
KC-Sizer
Company Name
Coopersurgical, Inc.
Labeler DUNS
801895244
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
4
Public Version Date
2024-02-28
Public Version Status
Update
Public Device Record Key
66818460-c4ff-4c64-b535-b138f50d5578

Device Description

Cervical Sizer

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
Yes
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
Moist Heat or Steam Sterilization

Product Codes

Code Name
KOH Instrument, Manual, General Obstetric-Gynecologic

GMDN Terms

Code Name
13644 Uterine sound, reusable

Identifiers

Type ID
Primary 00888937011135