FDA.report

Sterile Surgical Sponges

Primary DI
00616784334325
Brand
Sterile Surgical Sponges
Company
DYNAREX CORPORATION
Model
3343
Device description
Sterile Surgical Sponges, 4"x4", 12-ply, 2's, All Gauze
Published
2021-04-22
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

Related Records

Product Codes

CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784334325PackageGS125In Commercial Distribution
00616784334332PackageGS124In Commercial Distribution
00616784334318PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810180843331Durma+ DynaRule Disposable Paper Rulers30062026-03-24
00810180845106Cotton Tipped Wood Applicators, Sterile43042022-04-22
00810180845113Cotton Tipped Wood Applicators, Sterile43052022-04-22
00810180840712CurPro Dermal Curettes,2 mm 41552024-12-16
00840117347892Medi-Cut Safety Scalpel41652022-04-17
00810180844901Disposable Prep Razors42512020-11-02
00810180844918Medicine Cups 1oz 42522024-10-28
00810180844925LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal 42542021-06-21
00810180844703Bandage Shears 7.5" Orange4183-BX2020-11-08
00810180844710Bandage Shears 7.5" Purple4184-BX2020-11-08
00810180844840Emesis Basin42242022-05-02
00810180844857Sitz Bath42282021-09-01
00810180844864Urinal- Male42292021-09-01
00810180844871Bed Pans42302021-04-22
00810180844888Bed Pans42312021-04-22
00810180844895Nuns Cap Specimen Collector42322021-04-22
00840117331822DynaSafety Heavy Duty Woven Fabric Knuckle Bandages, 1 1/2" x 3"3765BULK2024-03-08
00840117331853DynaSafety Heavy Duty Woven Fabric Bandages, Large Patch, 2" x 3"3766BULK2024-03-08
00840117331907DynaSafety Heavy Duty Woven Fabric Bandages, Sterile, 7/8" x 3"3767BULK2024-03-08
00840117350045Pill Crusher Pouch42102021-09-01

Other Devices Sharing Product Codes

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