Dp4

GUDID 08720261025810

Device Sleeve - Box of 33

Equipmed USA B.V.

Medical equipment handle cover, single-use
Primary Device ID08720261025810
NIH Device Record Key43375869-aebc-4c38-809b-f4d418cde316
Commercial Distribution StatusIn Commercial Distribution
Brand NameDp4
Version Model NumberDP4-SLEEVE-USC-33-1
Company DUNS493118351
Company NameEquipmed USA B.V.
Device Count33
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108720261025810 [Unit of Use]
GS108720261027074 [Primary]

FDA Product Code

QAIPowered microneedle device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-01
Device Publish Date2023-04-21

On-Brand Devices [Dp4]

08720261025810Device Sleeve - Box of 33
08720261027067Microneedling Device
08720261022529Cartridges - Box of 33

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