FDA UDI In Commercial Distribution 🇺🇸 United States

ProSpore

DI: M985PS4501 · Model: 10e4 · MESA LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50

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Basic Information

Brand Name
ProSpore
Primary DI
M985PS4501
Version / Model
10e4
Catalog Number
PS-4-50
Company Name
MESA LABORATORIES, INC.
Labeler DUNS
102530326
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2017-10-20
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
c2477c16-eadc-4009-98df-a1a68a0d3b60

Device Description

ProSpore 4 mL ampoule for steam. 50 count

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FRC Indicator, Biological Sterilization Process

GMDN Terms

Code Name
13732 Biological sterilization indicator

Identifiers

Type ID
Primary M985PS4501
Unit of Use M985PS4500