Ear Specula - 8mm Non-Sterile

GUDID 09421902825835

ADEPT MEDICAL LIMITED

Self-retaining ear speculum
Primary Device ID09421902825835
NIH Device Record Keyfa7473d8-db5e-4139-9c71-d15192e4f575
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar Specula - 8mm Non-Sterile
Version Model NumberNZ3234-5
Company DUNS592534619
Company NameADEPT MEDICAL LIMITED
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 Usetrue
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109421902825835 [Primary]

FDA Product Code

EPYSpeculum, Ent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-29
Device Publish Date2024-04-19

On-Brand Devices [Ear Specula - 8mm Non-Sterile]

09421902825859NZ3234-100
09421902825835NZ3234-5

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