FDA UDI In Commercial Distribution 🇺🇸 United States

pjur Sampler Kit

DI: 00827160113216 · Model: pjur Sampler Kit 4 x 10ml - USA · Pjur Group Luxembourg SA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
pjur Sampler Kit
Primary DI
00827160113216
Version / Model
pjur Sampler Kit 4 x 10ml - USA
Company Name
Pjur Group Luxembourg SA
Labeler DUNS
400744553
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-12-04
Public Version
2
Public Version Date
2020-08-07
Public Version Status
Update
Public Device Record Key
c4783466-9d65-453f-aa8f-bf6f818e74e2

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
Yes
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
NUC Lubricant, Personal

GMDN Terms

Code Name
60412 Sexual lubricant

Identifiers

Type ID
Primary 00827160113216
Package 10827160113213
Package 40827160113214

Premarket Submissions

Submission Number Supplement Number
K010199 000
K133233 000
K141913 000