UltuCup Box Model 0 EN/FR/ES

GUDID 00628347063894

Pamco Distributing Inc

Menstrual cup, non-latex, reusable
Primary Device ID00628347063894
NIH Device Record Keyd8c10014-bf2e-4596-acc3-dae6ba88b035
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltuCup Box Model 0 EN/FR/ES
Version Model NumberModel 0
Company DUNS208394130
Company NamePamco Distributing Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100628347063894 [Primary]

FDA Product Code

HHECup, Menstrual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-22
Device Publish Date2024-08-14

Devices Manufactured by Pamco Distributing Inc

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00628347063870 - UltuCup Box Model 1 EN/FR/ES2024-08-26
00628347063894 - UltuCup Box Model 0 EN/FR/ES2024-08-22
00628347063894 - UltuCup Box Model 0 EN/FR/ES2024-08-22
00628347062736 - Harmony Latex Single Sleeve2024-06-07
00628347062774 - Harmony Polyisoprene Single Sleeve2024-06-07
00628347062729 - Harmony Latex Dam Bulk Box2024-04-02 Harmony Latex Dam Bulk Box 100/box
00628347065881 - Harmony Polyisoprene Dam Retail Pack 2024-04-02 Harmony Polyisoprene Dam Retail Pack 6/pack
00628347069810 - Harmony Latex Dam Retail Pack2024-04-02 Harmony Latex Dam Retail Pack 6/pack

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