FDA.reportPublic FDA data

BGEcare Sterile OR Towel

Primary DI
06972403300657
Brand
BGEcare Sterile OR Towel
Company
Xuchang Zhende Surgical Dressing Co., Ltd.
Model
OT051723010420S
Device description
BGEcare Sterile OR Towel 17"X23", Blue, 4 pieces/pack, 20 packs/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
06972403300657PackageGS120In Commercial Distribution
06972403300640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972403300657069724033006576972403300657
06972403300640069724033006406972403300640

GMDN Terms#

Term, Definition table
TermDefinition
Surgical towelA sterile cloth used in the operating room (OR) to absorb extraneous fluids. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
16931918102054HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918103969HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918107936HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918100913HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06
10197106935132CARDINAL HEALTHCardinal Health 200, LLCFRL2025-02-24
10810178830135Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830142Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830159Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830166Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830173Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830180Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10653160382928MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-01-15
10193489009460REMEDYMEDLINE INDUSTRIES, INC.FRL2024-10-24
10193489012521MEDLINEMEDLINE INDUSTRIES, INC.FRL2024-10-24
10850049784402SURGYCOSurgyco LLCFRL2023-12-15
10850049784419SURGYCOSurgyco LLCFRL2023-12-15
10810132041843HCSConcordance Healthcare Solutions LLCFRL2023-10-16
10884389108949MedlineMEDLINE INDUSTRIES, INC.FRL2023-10-12
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10850054813296Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813302Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813319Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813098Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12
10850054813104Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12