SAM ThoraSite®

GUDID 00822045001503

SAM ThoraSite®

SAM Medical Products

Needle guide, single-use
Primary Device ID00822045001503
NIH Device Record Key9e4f61d2-0d69-4fed-9a6e-b07322e219ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAM ThoraSite®
Version Model NumberTS200-1P
Company DUNS131084188
Company NameSAM Medical Products
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com
Phone503-639-5474
Emailregulatory@sammedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100822045001503 [Primary]
GS110822045001500 [Package]
Package: Inner Pack [25 Units]
In Commercial Distribution

FDA Product Code

GBXCatheter, Irrigation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-22
Device Publish Date2025-12-12

On-Brand Devices [SAM ThoraSite®]

40822045001129ThoraSite 25-Pack
30822045001122ThoraSite 5-Pack
00822045001503SAM ThoraSite®

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.