FDA.reportPublic FDA data

PRABADIN

Primary DI
10850051158246
Brand
PRABADIN
Company
Prabadin Corp
Model
PRGS4412PNS
Device description
Gauze sponge, 4x4x12ply, non sterile
Published
2024-05-17
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
00850051158188PackageGS110In Commercial Distribution
10850051158246PackageGS1200In Commercial Distribution
00850051158249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051158188008500511581888500511581880850051158188
1085005115824610850051158246
00850051158249008500511582498500511582490850051158249

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
786-547-8166sergio@medlife.us

Regulatory Flags#

DUNS number
100803924
Device count
1
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
00850051158232PRABADINPR71AC-16P2024-05-17
00850051158058PrabadinOR Towel2023-04-28
00850051158119Prab-PadsPrab-Pads2023-08-25
00850051158126Prab-PadsPrab-Pads2023-08-25
00850051158249PRABADINPRGS4412PNS2024-05-17
00850051158256PRABADIN4HQ5-XXX2024-05-17
00850051158263PRABADIN2RFJ-4091002024-05-17
10850051158215PRABADINPR71AC-16P2024-05-17
10850051158253PRABADIN4HQ5-XXX2024-05-17
10850051158260PRABADIN2RFJ-4091002024-05-17
00850051158140PRABADINPR4GQ2-10C2024-05-06
00850051158157PRABADINPR0506-0652024-05-06
00850051158164PRABADINPR0506-0702024-05-06
00850051158201PRABADINPR0507-0902024-05-06
00850051158133PRABADINPRPG3242WT2024-05-06
00850051158195PRABADINPR4GQ2-10C2024-05-06
10850051158154PRABADINPR0506-0652024-05-06
10850051158161PRABADINPR0506-0702024-05-06
10850051158208PRABADINPR0507-0902024-05-06
10850051158116Prab-PadsPrab-Pads2023-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D832CFT11PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832FT11PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAP21PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAP31PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAPR21PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAPR31PlasdentPLASDENT CORPORATIONNAB2026-10-13
M689HHMTG01020MiniTAC GauzeSafeguard US Operating, LLCNAB2026-10-13
00050428143117CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
00050428339763CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
00050428343869CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
10885380207150CurityCardinal Health 200, LLCNAB2026-10-08
10885380207167CurityCardinal Health 200, LLCNAB2026-10-08
10885380207174CurityCardinal Health 200, LLCNAB2026-10-08
50885380207202CurityCardinal Health 200, LLCNAB2026-10-08
50885380207219CurityCardinal Health 200, LLCNAB2026-10-08
50885380207226CurityCardinal Health 200, LLCNAB2026-10-08
50885380207233CurityCardinal Health 200, LLCNAB2026-10-08
50885380207240CurityCardinal Health 200, LLCNAB2026-10-08
50885380207257CurityCardinal Health 200, LLCNAB2026-10-08
06975675784750RESCUE RESSENTIALSEMSRUN GROUPNAB2026-09-22
00810194401671AiraAIRA, LLCNAB2026-08-26
06979931947972TempoXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-08-21
06979032641168Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
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