FDA.reportPublic FDA data

None

Primary DI
00886874115688
Brand
None
Company
INTUITIVE SURGICAL, INC.
Model
430048
Device description
SP CLEANING AND STERILIZATION KIT
Published
2018-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FFYAdaptor, bulbs, miscellaneous, for endoscope
MNLACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886874115688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886874115688008868741156888868741156880886874115688

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope cleaning brush, reusableA device used to remove dirt or debris from the working channel(s) and irregular surface of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube or metal coil with plastic bristles. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
938647021
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886874121917Sureform48230B2022-05-11
00886874121924Sureform48230W2022-05-11
00886874121931Sureform48230M2022-05-11
00886874124871Ion Tomosynthesis Board3804562025-11-11
00886874111116EndoWrist;daVinci Si4103222016-08-03
00886874112069EndoWrist4280802016-08-03
00886874112106Single-Site; daVinci Si4280932016-08-03
00886874113707Single-Site4780802016-07-08
00886874113738Single-Site4780932016-08-03
00886874115664Endowrist4804222018-05-04
00886874117309da Vinci Energy4804402019-12-10
00886874120736Force Feedback4751722024-03-21
00886874120743Force Feedback4752052024-03-21
00886874123362da Vinci Energy4805222025-08-14
00886874125649Force Feedback4771722026-03-26
00886874125656Force Feedback4772052026-03-26
00886874125571Force Feedback4761722025-01-29
00886874125588Force Feedback4762052025-01-29
00886874123447EndoWrist SP4301512024-12-09
00886874123454EndoWrist SP4301002024-12-09

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