Pannus Retention System

GUDID 10855459008049

Stetrix, Inc.

Limb/torso/head restraint, single-use
Primary Device ID10855459008049
NIH Device Record Keyc4630c3d-442e-4754-b693-2194ff940c63
Commercial Distribution StatusIn Commercial Distribution
Brand NamePannus Retention System
Version Model NumberTRS-06
Company DUNS827509667
Company NameStetrix, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855459008042 [Primary]
GS110855459008049 [Package]
Contains: 00855459008042
Package: [10 Units]
In Commercial Distribution

FDA Product Code

HXTTape, Orthopedic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-20
Device Publish Date2025-01-10

On-Brand Devices [Pannus Retention System]

10855459008056TRS-08
10855459008049TRS-06
00855459008004TRS-04

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