Rowley Biochemical Hyaluronidase Powder SO-351

GUDID SO351852042008

Hyaluronidase Powder

TRANSENE COMPANY, INC.

Biological stain IVD
Primary Device IDSO351852042008
NIH Device Record Key178681a6-e28b-4cba-9cda-a08ad12c42aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameRowley Biochemical Hyaluronidase Powder
Version Model Number1
Catalog NumberSO-351
Company DUNS044815983
Company NameTRANSENE COMPANY, 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCSO351852042008 [Primary]

FDA Product Code

IBDHyaluronidase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-24
Device Publish Date2019-09-16

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