FDA.reportPublic FDA data

Boston Scientific

Primary DI
06921865500020
Brand
Boston Scientific
Company
Jianerkang Medical Co., Ltd
Model
SMG-218-2000
Published
2020-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06921865500020PrimaryGS10
26921865500000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06921865500020069218655000206921865500020
2692186550000026921865500000

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricantA substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
530968767
Device count
2000
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06921865500099EndoGlide+™M00501900M00501900 2022-04-15
06921865500105EndoGlide+™M00501903M005019032022-04-15
16921865500034EndoGlide+™SLT-395-102022-05-18
16921865500041EndoGlide+™SLT-394-202022-05-18
26921865500055EndoGlide+™SLT-395-502022-05-18
26921865500062EndoGlide+™SLT-394-1002022-05-18
06921865500273EndoGlide+™SLT-3952022-05-18
06921865500280EndoGlide+™SLT-3942022-05-18
06921865500013Boston ScientificSMG-218-2002020-11-06
06921865500037Boston ScientificSMG-2182020-11-06
36921865500090Boston ScientificSLT-395-102022-05-18
36921865500076Boston ScientificSLT-394-202022-05-18
36921865500106Boston ScientificSLT-395-502022-05-18
36921865500083Boston ScientificSLT-394-1002022-05-18
36921865500052Boston ScientificM005019012022-04-15
36921865500038Boston ScientificM005019042022-04-15
36921865500069Boston ScientificM005019022022-04-15
36921865500045Boston ScientificM005019052022-04-15
36921865500007Boston ScientificSMG-218-2002020-11-06
26921865500000Boston ScientificSMG-218-20002020-11-06

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