FDA.reportPublic FDA data

Advantage Surgical Sponge

Primary DI
00616784326429
Brand
Advantage Surgical Sponge
Company
Dynarex Corporation
Model
3264
Device description
"Advantage Surgical Sponges, 8 ply, 4""x4"""
Published
2021-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00616784326436PackageGS120In Commercial Distribution
00616784326429PrimaryGS10
00810180844239Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784326436006167843264366167843264360616784326436
00616784326429006167843264296167843264290616784326429
00810180844239008101808442398101808442390810180844239

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spongeA non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
200
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117311411Resp-O2 Nasal O2 Cannula Cushion Tip331542021-04-22
00840117311435Resp-O2 Nasal O2 Cannula Cushion Tip331552021-04-22
00840117311459Resp-O2 Nasal O2 Cannula Cushion Tip331562021-04-22
00840117311473Resp-O2 Nasal O2 High Flow Cannula331602021-04-22
00840117311718Resp-O2 Nasal Oxygen Cannula Deluxe Ear Foam Covers333002021-04-22
00840117316416Resp-O2 Nasal O2 Cannula Cushion Tip331702021-04-22
00840117316423Resp-O2 Nasal O2 Cannula Cushion Tip331712021-04-22
00840117316430Resp-O2 Nasal O2 Cannula Cushion Tip331722021-04-22
00840117316447Resp-O2 Nasal O2 Cannula Cushion Tip331732021-04-22
00840117316454Resp-O2 Nasal O2 Cannula Cushion Tip331742021-04-22
00840117316461Nasal O2 Cannula Cushion Tip331752021-04-22
00840117316478Resp-O2 Nasal O2 Cannula Cushion Tip331762021-04-22
00840117316577Resp-O2 EtCO2 Nasal Sampling Cannula331802021-04-22
00840117316584Resp-O2 EtCO2 Nasal Sampling Cannula331812021-04-22
00840117316591Resp-O2 EtCO2 Nasal Sampling Cannula331822021-04-22
00840117316607Resp-O2 EtCO2 Nasal Sampling Cannula331832021-04-22
00840117316614Resp-O2 EtCO2 Nasal Sampling Cannula331842021-04-22
00840117316621Resp-O2 EtCO2 Nasal Sampling Cannula331852021-04-22
00840117316638Resp-O2 EtCO2 Nasal Sampling Cannula331862021-04-22
00840117316645Resp-O2 EtCO2 Nasal Sampling Cannulas331872021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979032641168Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
06979032641175Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
00197344173993CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00197344174006CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00840456203330JMUJMU DENTAL, INCNAB2026-06-23
00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
G242YCBJMR9Techno-AideTechno-Aide, Inc.NAB2025-09-12
G242YCAYMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCCCMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCETMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCADMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAKMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCASMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBHMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBOMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCDAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEPMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCABMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCACMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAEMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAGMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAHMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAJMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05