Transseptal Needle TSN098

GUDID 30858769006211

98cm Transseptal Needle Curve 0

PPMDM

Cardiac transseptal needle
Primary Device ID30858769006211
NIH Device Record Key9e2a6075-c382-4447-88c5-021f0390375b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransseptal Needle
Version Model NumberTSN098
Catalog NumberTSN098
Company DUNS081047841
Company NamePPMDM
Device Count1
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 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
GS100858769006210 [Primary]
GS130858769006211 [Package]
Contains: 00858769006210
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRCTrocar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-31
Device Publish Date2018-11-28

On-Brand Devices [Transseptal Needle]

3085876900625998cm Transseptal Needle Curve 1
3085876900624289cm Transseptal Needle Curve 1
0085876900623471cm Transseptal Needle Curve 1
3085876900621198cm Transseptal Needle Curve 0
3085876900620489cm Transseptal Needle Curve 0
3085876900619871cm Transseptal Needle Curve 0

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