FDA.report

CARDINAL HEALTH

Primary DI
50195594951960
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE31BCNMC
Catalog number
SNE31BCNMC
Device description
BRAIN COTTON PACK
Published
2021-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EFNCOTTON, ROLL

Product Code Classifications

CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594951960PackageGS120In Commercial Distribution
10195594951962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559495196050195594951960
1019559495196210195594951962

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810194401794AiraAIRA, LLCEFN2026-01-16
00810124536909Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-12-05
10810132808200House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
00840456214947JMUJMU DENTAL, INCEFN2025-07-15
00840456214954JMUJMU DENTAL, INCEFN2025-07-15
00840456214961JMUJMU DENTAL, INCEFN2025-07-15
00840456214978JMUJMU DENTAL, INCEFN2025-07-15
20810132044285HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
20810132044278HCSConcordance Healthcare Solutions LLCEFN2025-03-05
D77810701992Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
00304040184806Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184813Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184820Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184851Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184868Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00850053289538SURGYCOSurgyco LLCEFN2024-08-09
00850053289545SURGYCOSurgyco LLCEFN2024-08-09
00304040184837Henry ScheinHENRY SCHEIN, INC.EFN2024-06-26
00304040184844Henry ScheinHENRY SCHEIN, INC.EFN2024-06-26
00854014003270SAFE DENTBGSS Company Inc.EFN2024-05-01
00854014003300SAFE DENTBGSS Company Inc.EFN2024-05-01
00854014003348SAFE DENTBGSS Company Inc.EFN2024-05-01
00854014003379SAFE DENTBGSS Company Inc.EFN2024-05-01
20815878025321Burkhart Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2024-04-09
20815878027585Burkhart Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2024-04-09
20815878028483Burkhart Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2024-04-09
00653078997552Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2023-12-15
00810124531225Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2023-12-15
00810124531218Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2023-12-15
D79620001MARK3CARGUS INTERNATIONAL, INCEFN2023-08-01