FDA UDI In Commercial Distribution 🇺🇸 United States

H/STYLET™

DI: 00888937015980 · Model: 61-0020 · Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
H/STYLET™
Primary DI
00888937015980
Version / Model
61-0020
Company Name
Coopersurgical, Inc.
Labeler DUNS
801895244
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-10-04
Public Version
4
Public Version Date
2024-02-28
Public Version Status
Update
Public Device Record Key
48aecddf-29c1-4894-9ca0-75c686f12b21

Device Description

H/STYLET™ for use with H/S Catheters

Device Characteristics

Single Use
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HDQ Dilator, Cervical, Fixed Size

GMDN Terms

Code Name
34157 Salpingographic catheter

Identifiers

Type ID
Package 20888937015984
Primary 00888937015980