FDA.reportPublic FDA data

Elasto-Gel

Primary DI
00745713980002
Brand
Elasto-Gel
Company
Southwest Technologies, Inc.
Model
DR8000
Catalog number
2-025-001
Device description
4" x 4" 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
00745713980002PackageGS120In Commercial Distribution
00745713580004PrimaryGS10
00745713180006Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745713980002007457139800027457139800020745713980002
00745713580004007457135800047457135800040745713580004
00745713180006007457131800067457131800060745713180006

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
00745713486009Elasto-GelDR86002-025-0022023-02-21
00745713995013StimulenST95012-200-0252023-02-21
00745713095157StimulenST95152-200-0362023-02-21

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