FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040153769
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702631
Catalog number
5702631
Device description
Guaze Sponge Sterile
Published
2021-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040153769PackageGS130In Commercial Distribution
10304040153762PrimaryGS10
00304040153765Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404015376920304040153769
1030404015376210304040153762
00304040153765003040401537653040401537650304040153765

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
012430880
Device count
40
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979109839986GAUZE SWABSXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-03-16
20763000888989MerocelMEDTRONIC XOMED, INC.NAB2026-03-08
20763000888996MerocelMEDTRONIC XOMED, INC.NAB2026-03-08
00851587006073XGAUZE Trauma PadRevmedx, Inc.NAB2026-02-25
20665973020918DukalDukal LLCNAB2026-01-30
20665973020932DukalDukal LLCNAB2026-01-30
00810194401763AiraAIRA, LLCNAB2026-01-16
00810194401770AiraAIRA, LLCNAB2026-01-16
00810194401787AiraAIRA, LLCNAB2026-01-16
00810194401824AiraAIRA, LLCNAB2026-01-16
00810194401831AiraAIRA, LLCNAB2026-01-16
00810194401848AiraAIRA, LLCNAB2026-01-16
00810194401855AiraAIRA, LLCNAB2026-01-16
00723896029558Practicon® Standard 2x2 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029589Practicon® Premium 2x2 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029619Practicon® Standard 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029640Practicon® Premium 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00840456217009JMUJMU DENTAL, INCNAB2025-12-31
00840456217856JMUJMU DENTAL, INCNAB2025-12-31
00840456217863JMUJMU DENTAL, INCNAB2025-12-31
06931918102354AllesetGRI Medical & Electronic Technology Co., Ltd.NAB2025-12-16
10815555025593CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025609CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025715CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025616CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025692CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025708CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
08809968572930Soosung Non-Woven Fabricsoosung medicalNAB2025-12-10
08809968572954Soosung Non-Woven Fabricsoosung medicalNAB2025-12-10
08809968572978Soosung Non-Woven Fabricsoosung medicalNAB2025-12-10