FDA UDI In Commercial Distribution 🇺🇸 United States

HYST 2,9/30/300 AK HD COVIDIEN

DI: 04035873071419 · Model: 8300057945 · Henke-Sass, Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HYST 2,9/30/300 AK HD COVIDIEN
Primary DI
04035873071419
Version / Model
8300057945
Catalog Number
8300057945
Company Name
Henke-Sass, Wolf GmbH
Labeler DUNS
317326411
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-16
Public Version
2
Public Version Date
2023-11-17
Public Version Status
Update
Public Device Record Key
00960c25-6b4f-43c2-8b1e-8aa6ab6e0f6d

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
Yes
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
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
HIH Hysteroscope (And Accessories)

GMDN Terms

Code Name
36628 Rigid optical hysteroscope

Identifiers

Type ID
Primary 04035873071419

Device Sizes

Type Value Unit Text
Outer Diameter 2.9 Millimeter