FDA.report

Henry Schein

Primary DI
10304040119232
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701653
Catalog number
5701653
Device description
Laparotomy Pack 4
Published
2020-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FDElaparoscopy kit

Product Code Classifications

CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040119232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1030404011923210304040119232

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile 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
Ethylene Oxide

Regulatory Flags

DUNS number
012430880
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
true

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