FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439920572
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
FGS-045
Catalog number
FGS-045
Device description
SCISSOR WIRE CUTTER 4.75 IN ST
Published
2021-01-29
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

Product Codes#

Code, Name table
CodeName
JYASCISSORS, WIRE CUTTING, ENT, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYAScissors, Wire Cutting, Ent, SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439920572PackageGS120In Commercial Distribution
10888439920574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843992057250888439920572
1088843992057410888439920574

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811870037986Manus Medical, LLCManus Medical, LLCJYA2024-02-07
20811870037980Manus Medical, LLCManus Medical, LLCJYA2024-02-07
10888439920574CARDINAL HEALTHCardinal Health 200, LLCJYA2021-01-29
04038653149063DUROTIPAesculap AGJYA2020-04-21
04038653038312AESCULAPAesculap AGJYA2020-04-20
00888118014429SCISSORSKLS-Martin L.P.JYA2018-09-26
00888118014436SCISSORSKLS-Martin L.P.JYA2018-09-26
00888118014443SCISSORSKLS-Martin L.P.JYA2018-09-26
10885403012525V. MuellerSTERIS CORPORATIONJYA2018-08-02
10885403010811V. MuellerSTERIS CORPORATIONJYA2018-07-13