FDA UDI In Commercial Distribution 🇺🇸 United States

MedGyn Gynescope

DI: M803010200 · Model: AL-102 · MEDGYN PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
MedGyn Gynescope
Primary DI
M803010200
Version / Model
AL-102
Catalog Number
010200
Company Name
MEDGYN PRODUCTS, INC.
Labeler DUNS
103913430
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-08
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
5f6fec7a-eade-4467-a505-a2194e576ff0

Device Description

MedGyn Gynescope (Colposcope)

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
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HEX Colposcope (And Colpomicroscope)

GMDN Terms

Code Name
10960 Colposcope

Identifiers

Type ID
Primary M803010200