FDA.reportPublic FDA data

Elasto-Gel

Primary DI
00745713486009
Brand
Elasto-Gel
Company
Southwest Technologies, Inc.
Model
DR8600
Catalog number
2-025-002
Device description
6" x 8" Sterile Wound Dressing
Published
2023-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872165000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872165000ELASTO-GEL OCCLUSIVE DRESSINGSouthwest Technologies, Inc.1987-06-26FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00745713486009PackageGS125In Commercial Distribution
00745713586006PrimaryGS10
00745713186008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745713486009007457134860097457134860090745713486009
00745713586006007457135860067457135860060745713586006
00745713186008007457131860087457131860080745713186008

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)247-9951quality@elastogel.com

Regulatory Flags#

DUNS number
048078018
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00745713000021HydrelixHDX0017-200-0012025-09-11
00745713000038HydrelixHDX0057-200-0022025-09-11
00745713000014HydrelixHDX0017-200-0012025-09-11
00745713000045HydrelixHDX0057-200-0022025-09-11
00745713186015BioColAWC018-050-0012023-02-21
00745713186022BioColAWC028-050-0022023-02-21
00745713695012StimulenST95012-200-0252023-02-21
00745713695159StimulenST95152-200-0362023-02-21
00745713082003Elasto-GelDR82002-025-0082023-02-21
00745713580004Elasto-GelDR80002-025-0012023-02-21
00745713586006Elasto-GelDR86002-025-0022023-02-21
00745713982006Elasto-GelDR82002-025-0082023-02-21
00745713086018BioColAWC018-050-0012023-02-21
00745713086025BioColAWC028-050-0022023-02-21
00745713980002Elasto-GelDR80002-025-0012023-02-21
00745713995013StimulenST95012-200-0252023-02-21
00745713095157StimulenST95152-200-0362023-02-21

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