FDA UDI In Commercial Distribution 🇺🇸 United States

MedGyn Pessary Gellhorn w/drain #5

DI: M803050159 · Model: Pessary Gellhorn w/drain #5 · MEDGYN PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
MedGyn Pessary Gellhorn w/drain #5
Primary DI
M803050159
Version / Model
Pessary Gellhorn w/drain #5
Catalog Number
050159
Company Name
MEDGYN PRODUCTS, INC.
Labeler DUNS
103913430
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-31
Public Version
3
Public Version Date
2019-11-08
Public Version Status
Update
Public Device Record Key
558c8c1c-89bf-40e4-b016-7f196bca171a

Device Description

Pessary ring is used to treat uterine prolapse.

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
MR Safe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HHW Pessary, Vaginal

GMDN Terms

Code Name
34149 Pelvic-organ-supporting pessary

Identifiers

Type ID
Primary M803050159