FDA.reportPublic FDA data

Blue Beacon(TM) GI Marker

Primary DI
06932503562065
Brand
Blue Beacon(TM) GI Marker
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
DYZ-08-10
Device description
Product is dark blue solution, the concentration is 0.8%, the content is 10ml. Initial packaging is the vial.
Published
2023-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
16932503562062PackageGS110In Commercial Distribution
26932503562069PackageGS110In Commercial Distribution
06932503562065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250356206216932503562062
2693250356206926932503562069
06932503562065069325035620656932503562065

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Contacts#

Phone, Email table
PhoneEmail
877-552-4027info@micro-tech-usa.com

Regulatory Flags#

DUNS number
530269083
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932503540353Disposable Biopsy Forceps1005751005752020-03-23
06932503540360Disposable Biopsy Forceps1005761005762020-03-23
06932503540377Disposable Biopsy Forceps1005771005772020-03-23
06932503540384Disposable Biopsy Forceps1005781005782020-03-23
06932503510219Pulmonary Hydro-Slide GuidewireGW-35/182026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireGW-35/262026-05-29
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeCDS220092026-05-15
06932503516112Sphincterotome / short-wire compatibleRDSP-0525-121-12026-05-08
06932503516129Sphincterotome / short-wire compatibleRDSP-0525-221-12026-05-08
06932503516136Sphincterotome / short-wire compatibleRDSP-0525-131-12026-05-08
06932503516143Sphincterotome / short-wire compatibleRDSP-0525-231-12026-05-08
06932503516150Sphincterotome / short-wire compatibleRDSP-0530-111-12026-05-08
06932503516167Sphincterotome / short-wire compatibleRDSP-0530-211-12026-05-08
06932503516174Sphincterotome / short-wire compatibleRDSP-0530-121-12026-05-08
06932503516181Sphincterotome / short-wire compatibleRDSP-0530-221-12026-05-08
06932503516198Sphincterotome / short-wire compatibleRDSP-0530-131-12026-05-08
06932503516204Sphincterotome / short-wire compatibleRDSP-0530-231-12026-05-08
06932503575379Sphincterotome / short-wire compatibleRDSP-0220-1112026-05-08
06932503575386Sphincterotome / short-wire compatibleRDSP-0220-2112026-05-08
06932503575393Sphincterotome / short-wire compatibleRDSP-0220-1212026-05-08

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
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
00724995216528NAUS EndoscopyNBG2022-01-28
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