FDA.reportPublic FDA data

Henry Schein

Primary DI
H65857030615
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703061
Catalog number
5703061
Device description
Tray Pain F/ Clearway Pain
Published
2022-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65857030615PrimaryHIBCC0
H65857030611Unit of UseHIBCC0

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.

Regulatory Flags#

DUNS number
012430880
Device count
20
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
H65857032365Henry ScheinHENRY SCHEIN, INC.OFQ2022-12-12
H65857032105Henry ScheinHENRY SCHEIN, INC.OFQ2022-10-25
H65857032025Henry ScheinHENRY SCHEIN, INC.OFQ2022-09-19
10195594520434CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-09-02
10195594516130CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-07-21
10195594419592CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-05-09
10195594547585CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-04-06
10195594375423CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594516338CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594530839CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594509859CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-14
10195594450717CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-10
10195594501136CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519902CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519919CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594492106CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-01
10195594476199CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-26
10195594548438CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-24
10195594550127CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-24
10195594544065CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-21
10195594545475CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-21
10195594456221CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-15
10195594487225CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-11
10195594500009CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594520601CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594527860CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594461188CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-08
10195594503772CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07
10195594520533CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07
10195594540340CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07