FDA.reportPublic FDA data

BGEcare Sterile Non-woven Sponge

Primary DI
06972403420263
Brand
BGEcare Sterile Non-woven Sponge
Company
Henan Zhende Medical Products Co., Ltd.
Model
NS09020206023520S
Device description
BGEcare Sterile Non-woven Sponge 2"X2", 6-Ply, 2 pieces/pack, 35 packs/box, 20 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
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972403420263PackageGS135In Commercial Distribution
06972403420270PackageGS120In Commercial Distribution
06972403420256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972403420263069724034202636972403420263
06972403420270069724034202706972403420270
06972403420256069724034202566972403420256

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
544509489
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
06972403420102BGEcare Sterile Non-woven SpongeNS06040404023520S2021-03-08
06972403420171BGEcare Sterile Non-woven SpongeNS06030304025024S2021-03-08
06972403420225BGEcare Sterile Non-woven SpongeNS06020204025030S2021-03-08
06972403420256BGEcare Sterile Non-woven SpongeNS09020206023520S2021-03-08
06972403420287BGEcare Sterile Non-woven SpongeNS09040406022512S2021-03-08
06972403423110BGE careM14220C2023-06-29
06972403420003BGEcare Elastic Bandage with Self-closureEB070205011206NS2021-03-08
06972403420027BGEcare Elastic Bandage with Self-closureEB070405011206NS2021-03-08
06972403420041BGEcare Self Adhesive Non-woven BandageCB080205011806NS2021-03-08
06972403420072BGEcare Self Adhesive Non-woven BandageCB080405011806NS2021-03-08
06972403420133BGEcare Non-sterile Non-woven SpongeNS0604040420010NS2021-03-08
06972403420157BGEcare Non-sterile Non-woven SpongeNS0603030420020NS2021-03-08
06972403420201BGEcare Non-sterile Non-woven SpongeNS0602020420020NS2021-03-08
06972403420010BGEcare Elastic Bandage with Self-closureEB070205011206NS2021-03-08
06972403420034BGEcare Elastic Bandage with Self-closureEB070405011206NS2021-03-08
06972403420058BGEcare Self Adhesive Non-woven BandageCB080205011806NS2021-03-08
06972403420089BGEcare Self Adhesive Non-woven BandageCB080405011806NS2021-03-08
06972403420119BGEcare Sterile Non-woven SpongeNS06040404023520S2021-03-08
06972403420140BGEcare Non-sterile Non-woven SpongeNS0604040420010NS2021-03-08
06972403420164BGEcare Non-sterile Non-woven SpongeNS0603030420020NS2021-03-08

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