Wellstar Uterine Fibroid Embolization

GUDID 00817395021745

Wellstar Uterine Fibroid Embolization

PACKROOM LLC

Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
Primary Device ID00817395021745
NIH Device Record Keybd22ba96-78b7-4b87-9ae0-3221d2dc1941
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellstar Uterine Fibroid Embolization
Version Model NumberWS195
Company DUNS015179820
Company NamePACKROOM LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100817395021745 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-24
Device Publish Date2020-04-16

On-Brand Devices [Wellstar Uterine Fibroid Embolization ]

00817395021745Wellstar Uterine Fibroid Embolization
00817395022919Wellstar Uterine Fibroid Embolization

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