PRABADIN

Primary DI
10850051158215
Brand
PRABADIN
Company
Prabadin Corp
Model
PR71AC-16P
Device description
Gauze sponge, 4x4x16ply, Xray detectable, 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
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051158218PackageGS164In Commercial Distribution
10850051158215PackageGS120In Commercial Distribution
00850051158232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051158218008500511582188500511582180850051158218
1085005115821510850051158215
00850051158232008500511582328500511582320850051158232

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

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
10850051158246PRABADINPRGS4412PNS2024-05-17
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
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10326053119542Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
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10326053119580Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
08600036785272USMEDCOUS MEDCO INCGDY2023-07-14
08600036785340USMEDCOUS MEDCO INCGDY2023-07-14
08600036785418USMEDCOUS MEDCO INCGDY2023-07-14
08600036785586USMEDCOUS MEDCO INCGDY2023-07-14
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