BGEcare Sterile Lap Sponge

Primary DI
06972403300626
Brand
BGEcare Sterile Lap Sponge
Company
Xuchang Zhende Surgical Dressing Co., Ltd.
Model
LS04181804051004S
Device description
BGEcare Sterile Lap Sponge 18"X18", 4-Ply, 5 pieces/pack, 10 packs/box, 4 boxes/carton box
Published
2021-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
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
06972403300626PackageGS110In Commercial Distribution
06972403300633PackageGS14In Commercial Distribution
06972403300619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972403300626069724033006266972403300626
06972403300633069724033006336972403300633
06972403300619069724033006196972403300619

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque woven surgical sponge, sterileA non-medicated sterile 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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
528104096
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979109839986GAUZE SWABSP162C1260012026-03-16
06972403300480BGEcare Sterile Gauze SpongeGS01040408025012S2021-03-11
06972403300985BGEcare Sterile Gauze SpongeGS01020208025030S2021-03-11
06972403301012BGEcare Sterile Gauze SpongeGS01030308025024S2021-03-11
06972403301043BGEcare Sterile Gauze SpongeGS01040408025012S-12021-03-11
06972403301074BGEcare Sterile Gauze SpongeGS01020212025045S2021-03-11
06972403301104BGEcare Sterile Gauze SpongeGS01030312024030S2021-03-11
06972403301135BGEcare Sterile Gauze SpongeGS01040412022524S2021-03-11
06972403307601Cardinal Health28700-NS12023-06-28
06972403307717CardinalHealth68342023-06-29
06972403307571ZDZ530M22012023-06-28
06972403307564ZDZ530M22012023-06-28
06972403300596BGEcare Sterile Lap SpongeLS041818040540S2021-03-11
06972403300619BGEcare Sterile Lap SpongeLS04181804051004S2021-03-08
06972403300534BGEcare Non-sterile Gauze SpongeGS0104041220010NS2021-03-11
06972403300558BGEcare Non-sterile Gauze SpongeGS0104041220020NS2021-03-11
06972403300909BGEcare Non-sterile Gauze SpongeGS0102020820025NS2021-03-11
06972403300947BGEcare Non-sterile Gauze SpongeGS0103030820020NS2021-03-11
06972403300497BGEcare Sterile Gauze SpongeGS01040408025012S2021-03-11
06972403300541BGEcare Non-sterile Gauze SpongeGS0104041220010NS2021-03-11

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