FDA UDI Not in Commercial Distribution 🇺🇸 United States

DISPETTE®

DI: 07612964013328 · Model: FH1500 · Guest Scientific AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
DISPETTE®
Primary DI
07612964013328
Version / Model
FH1500
Catalog Number
FH1500
Company Name
Guest Scientific AG
Labeler DUNS
483342734
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2019-11-07
Public Version
2
Public Version Date
2020-06-02
Public Version Status
Update
Public Device Record Key
1d7d7237-daee-4212-bf57-b06dc17a8c44
Distribution End Date
2020-06-01

Device Description

DISPETTE ONE

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JPH Test, Erythrocyte Sedimentation Rate

GMDN Terms

Code Name
55970 Erythrocyte sedimentation rate (ESR) IVD, kit

Identifiers

Type ID
Package 07612964013335
Primary 07612964013328
Unit of Use 07612964013342