FDA.reportPublic FDA data

MEDLINE

Primary DI
40888277844484
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA1371
Catalog number
DYNDA1371
Device description
STERILE GAUZE
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
40888277844484PackageGS140In Commercial Distribution
10888277844483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827784448440888277844484
1088827784448310888277844483

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
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
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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