FDA.reportPublic FDA data

Elasto-Gel

Primary DI
00745713586006
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
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

Contacts#

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

Regulatory Flags#

DUNS number
048078018
Device count
5
Lot or batch
true
Expiration date on label
true

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
00745713982006Elasto-GelDR82002-025-0082023-02-21
00745713086018BioColAWC018-050-0012023-02-21
00745713086025BioColAWC028-050-0022023-02-21
00745713980002Elasto-GelDR80002-025-0012023-02-21
00745713486009Elasto-GelDR86002-025-0022023-02-21
00745713995013StimulenST95012-200-0252023-02-21
00745713095157StimulenST95152-200-0362023-02-21

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