FDA.report

CARDINAL HEALTH

Primary DI
10885380154089
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SM-SUTRBAG
Catalog number
SM-SUTRBAG
Device description
Suture Bag, Small, Tabs, Clear
Published
2023-08-28
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
false

Related Records

Product Codes

CodeName
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380154087PrimaryGS10
10885380154089Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088538015408750885380154087
1088538015408910885380154089

GMDN Terms

TermDefinition
Suture removal kitA collection of various sterile instruments, dressings, and pharmaceuticals designed to remove sutures from a patient. It typically includes a disinfectant, scissors, forceps, gauze and bandages. This is a single-use device.

Device Sizes

TypeValueUnit
Height11.5Inch
Width10Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
500
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

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