TZ Medical Pressure Discs

GUDID 00811331010480

Round Universal Disc w/ Omega opening

Tz Medical, Inc.

Femoral artery compression system, manual, single-use
Primary Device ID00811331010480
NIH Device Record Key674beb5f-9a51-40c6-861e-efd9a0073b4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTZ Medical Pressure Discs
Version Model Number8880-04
Company DUNS793149709
Company NameTz Medical, Inc.
Device Count50
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811331010480 [Unit of Use]
GS110811331010487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

On-Brand Devices [TZ Medical Pressure Discs]

00811331013252Oval Universal Disc w/ Omega opening
00811331010480Round Universal Disc w/ Omega opening
00811331011838Large Round Universal Disc w/ Omega opening
00811331011715Oval Universal Disc
00811331013245Round Universal Disc

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