FDA.reportPublic FDA data

Wound-Care

Primary DI
G018WC90122412
Brand
Wound-Care
Company
Supply Line International Medical, LLC
Model
WC9012241
Device description
Gauze Sponge, 2" x 2", 12-PLY, Non-Sterile, (200/PK, 8,000/CS)
Published
2020-12-21
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

Contact Domains#

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
G018WC90122412PackageHIBCC40In Commercial Distribution
G018WC90122411PrimaryHIBCC0
G018WC90122419Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze pad, non-sterileA non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon, polyester, cellulose pulp) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-239-4058Info@SLIMedical.com

Regulatory Flags#

DUNS number
079241502
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
G018P850DC1Physicians ChoiceP850DC2023-06-12
G018DCC020Physicians ChoiceDCC-022022-12-09
G018DLH010Physician's ChoiceDLH012021-08-05
G018SN2301060Doctors ChoiceSN2301062021-03-25
G018SN2315060Doctors ChoiceSN2315062021-03-25
G018SN2501060Doctors ChoiceSN2501062021-03-25
G018SN2515060Doctors ChoiceSN2515062021-03-25
G018DLH012Physician's ChoiceDLH012021-08-05
G018SND25G1504Doctors ChoiceSND25G15042021-06-09
G018SND25G150401Doctors ChoiceSND25G15042021-06-09
G018SYS01LL070Doctors ChoiceSYS01072021-04-20
G018SYS01060Doctors ChoiceSYS01062021-03-25
G018SYS03060Doctors ChoiceSYS03062021-03-25
G018SN2301061Doctors ChoiceSN2301062021-03-25
G018SN2315061Doctors ChoiceSN2315062021-03-25
G018SN2501061Doctors ChoiceSN2501062021-03-25
G018SN2515061Doctors ChoiceSN2515062021-03-25
G018SYS01061Doctors ChoiceSYS01062021-03-25
G018SYS03061Doctors ChoiceSYS03062021-03-25
G018SYSR032515020Doctors ChoiceSYSR032515022021-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06979032641175Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
00197344173993CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00197344174006CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00840456203330JMUJMU DENTAL, INCNAB2026-06-23
00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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