FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10080196743902
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
MDS251536LF
Catalog number
MDS251536LF
Device description
"SPONGE,LAP,8""X36"",XRAY,ST,5/PK,40PK/CS"
Published
2021-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDYGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196743903PackageGS140In Commercial Distribution
10080196743902PrimaryGS10
00080196743905Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4008019674390340080196743903
1008019674390210080196743902
00080196743905000801967439050801967439050080196743905

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque woven surgical spongeA non-medicated device made from woven gauze (e.g., 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, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
5
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119528Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119535Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119542Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119559Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119566Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119573Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119580Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
08600036785272USMEDCOUS MEDCO INCGDY2023-07-14
08600036785340USMEDCOUS MEDCO INCGDY2023-07-14
08600036785418USMEDCOUS MEDCO INCGDY2023-07-14
08600036785586USMEDCOUS MEDCO INCGDY2023-07-14
08600036785654USMEDCOUS MEDCO INCGDY2023-07-14
10197106046968CARDINAL HEALTHCardinal Health 200, LLCGDY2023-07-12
20192253050339CurityCardinal Health 200, LLCGDY2023-03-27
20192253050346CurityCardinal Health 200, LLCGDY2023-03-27
10192253050288KerlixCardinal Health 200, LLCGDY2023-03-24
10665973000012DukalDukal LLCGDY2022-12-06
10665973000029DukalDukal LLCGDY2022-12-06
10665973000036DukalDukal LLCGDY2022-12-06
10665973000050DukalDukal LLCGDY2022-12-06
10665973000067DukalDukal LLCGDY2022-12-06
10665973000081DukalDukal LLCGDY2022-12-06