FDA.reportPublic FDA data

Resilient Medical Solutions

Primary DI
10850037100603
Brand
Resilient Medical Solutions
Company
Resilient Medical Solutions, LLC
Model
RMWC2
Device description
12-Ply USP Type VII Gauze Sponge, 4x4, Non-Sterile
Published
2023-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850037100603PackageGS110In Commercial Distribution
00850037100606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003710060310850037100603
00850037100606008500371006068500371006060850037100606

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
076404432
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850061262936Resilient Medical SolutionsRMEG12502026-05-20
00850061262943Resilient Medical SolutionsRMEG22502026-05-20
00850061262950Resilient Medical SolutionsRMEG32502026-05-20
00850061262967Resilient Medical SolutionsRMEG42502026-05-20
00850061262974Resilient Medical SolutionsRMEG52302026-05-20
00850061262981Resilient Medical SolutionsRMEM1Y2026-05-20
00850061262998Resilient Medical SolutionsRMEM1F2026-05-20
00850086117006Resilient Medical SolutionsRMEM22026-05-20
00850086117013Resilient Medical SolutionsRMTM1AFB2026-05-20
00850086117020Resilient Medical SolutionsRMTM3AFB2026-05-20
00850037100507Resilient Medical SolutionsRMTD12023-08-16
00850037100514Resilient Medical SolutionsRMTD22023-08-16
00850037100521Resilient Medical SolutionsRMSH3L2023-07-31
00850037100538Resilient Medical SolutionsRMSH5L2023-07-31
00850037100545Resilient Medical SolutionsRMSH10L2023-07-31
00850037100552Resilient Medical SolutionsRMSH20L2023-07-31
00850037100569Resilient Medical SolutionsRMSH50L2023-07-31
00850061262899Resilient Medical SolutionsRMTMDBS32025-05-16
00850061262905Resilient Medical SolutionsRMSOTHYU2025-05-16
00850061262912Resilient Medical SolutionsRMAM1YU2025-05-16

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Primary DI, Brand, Company table
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