FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040195437
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5705824
Catalog number
5705824
Device description
FACIAL PACK
Published
2026-03-17
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

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040195434PrimaryGS10
00304040195437Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404019543410304040195434
00304040195437003040401954373040401954370304040195437

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
6
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160522332HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522349HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522356HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522363HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522370HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522394HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522400HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522448HalyardAVID MEDICAL, INC.LRO2026-06-02
10198956004887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956245754CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956248908CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956312043CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314634CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314894CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956321717CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956356184CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956370760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956376793CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956377363CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384750CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384873CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385078CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385160CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956391970CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956406193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956439399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956440685CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444065CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444850CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956445833CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01