FDA.reportPublic FDA data

Plastcare

Primary DI
D915RIT44042
Brand
Plastcare
Company
Plastcare USA
Model
RIT-4404
Device description
Gauze Non Woven Sponges 4 x 4 Inch.
Published
2020-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
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
D915RIT44042PackageHIBCC10In Commercial Distribution
D915RIT44041PrimaryHIBCC0
D915RIT44040Unit 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

Regulatory Flags#

DUNS number
079299604
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
false
Expiration date on label
false
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
D915MBK21SentinelMBK22019-12-12
D915MBL21SentinelMBL22019-12-12
D915MPI21SentinelMPI22019-12-12
D915MWH21SentinelMWH22019-12-12
D915WHW1PlastcareWHW2020-05-01
D915WHW2PlastcareWHW2020-05-01
D915MBK22SentinelMBK22019-12-12
D915MBL22SentinelMBL22019-12-12
D915MPI22SentinelMPI22019-12-12
D915MWH22SentinelMWH22019-12-12
D915RIT50101PlastcareRIT-50102020-03-11
D915RIT50151PlastcareRIT-50152020-03-11
D915RIT50201PlastcareRIT-50202020-03-11
D915RIT50251PlastcareRIT-50252020-03-11
D915RIT50152PlastcareRIT-50152020-03-11
D915RIT50202PlastcareRIT-50202020-03-11
D915RIT50252PlastcareRIT-50252020-03-11
D915RIT50102PlastcareRIT-50102020-03-11
D915CLB1PlastcareCLB2020-03-10
D915K21061VergeK21062020-03-10

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Primary DI, Brand, Company table
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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
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