FDA.reportPublic FDA data

None

Primary DI
16945416405067
Brand
None
Company
MEIXIN MEDICAL SUZHOU CO., LTD.
Model
4-1124-5-G
Published
2023-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
16945416405067PrimaryGS10
46945416405068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1694541640506716945416405067
4694541640506846945416405068

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.

Regulatory Flags#

DUNS number
530231216
Device count
1000
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16945416401007NoneMTB400E2016-11-21
16945416401014NoneMTW4002016-11-21
16945416401021NoneMTG4002016-11-21
16945416401090None5-50422016-11-21
16945416401205NoneMTB36362016-11-21
16945416401229NoneMTB400X2017-01-18
16945416401045None MT4002017-10-23
16945416401199NoneMTB4002018-08-22
16945416401212None MT400032017-10-23
16945416403032NoneMG44122023-09-30
16945416403049NoneMG44162023-09-30
16945416403117None5-199172023-09-30
16945416403124None5-199182023-09-30
16945416403155None5-199252023-09-30
16945416403179None5-199272023-09-30
16945416403193None5-199302023-09-30
16945416403230None5-199352023-09-30
16945416404022NoneMN44042023-09-30
16945416404046None5-199292023-09-30
16945416406002NoneCS54802023-09-30

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
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
10665973000098DukalDukal LLCGDY2022-12-06
10665973000166DukalDukal LLCGDY2022-12-06