Meatal Dilator Pediatric MDP

GUDID 10812261012992

ALLWIN MEDICAL DEVICES, INC.

Endoscopic-access dilator, single-use
Primary Device ID10812261012992
NIH Device Record Keycb42e67c-9471-4e2f-bfd3-32d1b015ef5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeatal Dilator Pediatric
Version Model NumberMDP
Catalog NumberMDP
Company DUNS796354509
Company NameALLWIN MEDICAL DEVICES, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812261012995 [Primary]
GS110812261012992 [Package]
Contains: 00812261012995
Package: [10 Units]
In Commercial Distribution

FDA Product Code

KOEDilator, Urethral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-25
Device Publish Date2020-09-17

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