Elasto-Gel 2-025-002

GUDID 00745713486009

6" x 8" Sterile Wound Dressing

Southwest Technologies, Inc.

Wound hydrogel dressing, non-antimicrobial
Primary Device ID00745713486009
NIH Device Record Key1fc09669-14b3-4d53-871c-6e6d41e87909
Commercial Distribution StatusIn Commercial Distribution
Brand NameElasto-Gel
Version Model NumberDR8600
Catalog Number2-025-002
Company DUNS048078018
Company NameSouthwest Technologies, Inc.
Device Count5
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-Countertrue

Customer Support Contacts

Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com
Phone+1(800)247-9951
Emailquality@elastogel.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100745713186008 [Unit of Use]
GS100745713486009 [Package]
Contains: 00745713586006
Package: Case [25 Units]
In Commercial Distribution
GS100745713586006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, wound, drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-01
Device Publish Date2023-02-21

On-Brand Devices [Elasto-Gel]

007457134860096" x 8" Sterile Wound Dressing
007457139800024" x 4" Sterile Wound Dressing
007457139820062" x 3" Sterile Wound Dressing

Trademark Results [Elasto-Gel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELASTO-GEL
ELASTO-GEL
90903520 not registered Live/Pending
Southwest Technologies, Inc.
2021-08-26
ELASTO-GEL
ELASTO-GEL
74371744 not registered Dead/Abandoned
Southwest Technologies, Inc.
1993-03-25

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