FDA.reportPublic FDA data

Criterion Pure Freedom

Primary DI
10304040057503
Brand
Criterion Pure Freedom
Company
HENRY SCHEIN, INC.
Model
5700631
Catalog number
5700631
Device description
Criterion Pure Freedom Small
Published
2019-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QDOFentanyl and other opioid protection glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040057503PackageGS110In Commercial Distribution
00304040057506PrimaryGS10
20304040057500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404005750310304040057503
00304040057506003040400575063040400575060304040057506
2030404005750020304040057500

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00FALSE

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
200
DM exempt
true
Premarket exempt
false
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
true
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
10076490788657MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490788664MICROFLEX Ansell Healthcare ProductQDO2025-08-05
10076490788671MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490788688MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490788695MICROFLEXAnsell Healthcare ProductQDO2025-08-05
10076490708495KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490714397KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490716568KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490723740KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490737334KIMTECHAnsell Healthcare ProductQDO2025-07-21
10076490711426KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490735903KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490737518KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490744004KIMTECHAnsell Healthcare ProductQDO2025-07-03
10076490750999KIMTECHAnsell Healthcare ProductQDO2025-07-03
10686864061370Medicom AssureTouchAMD Medicom IncQDO2025-04-24
10686864061387Medicom AssureTouchAMD Medicom IncQDO2025-04-24
10686864061394Medicom AssureTouchAMD Medicom IncQDO2025-04-24
10686864061400Medicom AssureTouchAMD Medicom IncQDO2025-04-24
10686864061417Medicom AssureTouchAMD Medicom IncQDO2025-04-24
10686864061424Medicom AssureTouchAMD Medicom IncQDO2025-04-24
10686864061431Medicom AssureTouchAMD Medicom IncQDO2025-04-24
10686864061448Medicom AssureTouchAMD Medicom IncQDO2025-04-24
10697383978667AMMEX ProfessionalAMMEX CORPORATIONQDO2025-02-26
10697383978490AMMEX ProfessionalAMMEX CORPORATIONQDO2024-10-21
10697383978520AMMEX ProfessionalAMMEX CORPORATIONQDO2024-10-21
10304040186470Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11
10304040186609Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11
10304040186616Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11
10304040186623Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11