FDA.reportPublic FDA data

NA

Primary DI
00724995216528
Brand
NA
Company
US Endoscopy
Model
00711836
Catalog number
00711836
Device description
The Endoscopic Marker is a 5mL single-use solution designed to endoscopically mark lesions in the gastrointestinal tract.
Published
2022-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBGMarker, colon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBGMarker, ColonGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995216525PackageGS110In Commercial Distribution
50724995216523PackageGS112In Commercial Distribution
00724995216528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499521652510724995216525
5072499521652350724995216523
00724995216528007249952165287249952165280724995216528

GMDN Terms#

Term, Definition table
TermDefinition
Tissue marking inkA sterile liquid substance intended to be injected into tissue to identify lesions; it is also used externally on the skin to mark incision sites. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
46932503562711EndoINK(TM) Endoscopic MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
46932503562728EndoINK(TM) Endoscopic MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
06932503562713EndoINK(TM) Endoscopic MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
06932503562720EndoINK(TM) Endoscopic MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
16932503562710MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
16932503562727MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
56932503562718MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
56932503562725MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-07-31
05391530190527VueBluCOSMO SPANBG2023-07-21
05391530190541VueBluCOSMO SPANBG2023-07-21
16932503562864MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562871STA-BIL(TM) Non-migrating Endoscopic InkMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
06932503562010Blue Beacon(TM) GI MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
06932503562027Blue Beacon(TM) GI MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
06932503562058MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
06932503562065Blue Beacon(TM) GI MarkerMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562017MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562024MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562055MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
16932503562062MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
26932503562861MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
26932503562878MTMicro-Tech (Nanjing) Co., Ltd.NBG2023-06-28
10724995216525NAUS EndoscopyNBG2022-01-28
08809380059002Black EyeTHE STANDARD CO.,LTD.NBG2019-01-18
00893029002106Spot Ex Endoscopic TattooGI Supply, Inc.NBG2017-12-26
10893029002103Spot Ex Endoscopic TattooGI Supply, Inc.NBG2017-12-26
08809539692555Pointer Endoscopic MarkerOSTEONIC CO.,Ltd.NBG2017-05-12
00893029002069SPOT Endosopic MarkerGI Supply, Inc.NBG2016-09-24
00893029002441SPOT Endosopic MarkerGI Supply, Inc.NBG2016-09-24