ASSUREPlus®

GUDID D6870083005FG2

ASSUREPlus® Self-Sealing Sterilization Pouch 3.5 x 10 (89mm x 254mm) Box of 200

Sultan Healthcare Inc

Sterilization packaging, single-use
Primary Device IDD6870083005FG2
NIH Device Record Key0431fac1-ca58-4e92-b87d-1c37dd665ce8
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSUREPlus®
Version Model Number83005
Company DUNS056296981
Company NameSultan Healthcare Inc
Device Count200
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)989-8825
Emailxx@xx.xx

Device Dimensions

Length3.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD6870083005FG2 [Package]
Contains: D687830051
Package: Case [16 Units]
In Commercial Distribution
HIBCCD687830050 [Unit of Use]
HIBCCD687830051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-23

On-Brand Devices [ASSUREPlus®]

D6870083080FG2ASSUREPlus® Self-Sealing Sterilization Pouch 11 x 16 (279mm x 406mm) Box of 100
D6870083075FG2ASSUREPlus® Self-Sealing Sterilization Pouch 5.25 x 7.5 (133mm x 191mm) Box of 200
D6870083045FG2ASSUREPlus® Self-Sealing Sterilization Pouch 5.5 x 13 (140mm x 330mm) Box of 200
D6870083025FG2ASSUREPlus® Self-Sealing Sterilization Pouch 12 x 18 (305mm x 457mm) Box of 100
D6870083020FG2ASSUREPlus® Self-Sealing Sterilization Pouch 10 x 15 (254mm x 381mm) Box of 200
D6870083015FG2ASSUREPlus® Self-Sealing Sterilization Pouch 7 x 13 (178mm x 330mm) Box of 200
D6870083010FG2ASSUREPlus® Self-Sealing Sterilization Pouch 5.5 x 11 (140mm x 279mm) Box of 200
D6870083005FG2ASSUREPlus® Self-Sealing Sterilization Pouch 3.5 x 10 (89mm x 254mm) Box of 200
D6870083003FG2ASSUREPlus® Self-Sealing Sterilization Pouch 2.75 x 10 (70mm x 254mm) Box of 200
D6870083001FG2ASSUREPlus® Self-Sealing Sterilization Pouch 2.25 x 4 (57mm x 102mm) Box of 200
D6870083000FG2ASSUREPlus® Self-Sealing Sterilization Pouch 3.25 x 6.5 (83mm x 165mm) Box of 200

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