FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040152076
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702594
Catalog number
5702594
Device description
Criterion Non-woven Sponges Sterile
Published
2021-04-23
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
FRLFIBER, MEDICAL, ABSORBENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040152076PackageGS120In Commercial Distribution
10304040152079PrimaryGS10
00304040152072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404015207620304040152076
1030404015207910304040152079
00304040152072003040401520723040401520720304040152072

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
10304040195472Essentials570582857058282026-09-04
10304040195489Essentials570582957058292026-09-04
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536925007BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925014BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925021BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925038BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925045BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925052BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925069BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925076BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925083BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925090BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925106BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925113BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925120BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925137BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925144BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925151BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925168BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
20197344219428MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219442MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219459MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219466MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219473MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219480MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219497MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219503MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219435MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-13
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06