FDA.reportPublic FDA data

BlueBoost(TM) Submucosal Injectable Solution

Primary DI
06932503562515
Brand
BlueBoost(TM) Submucosal Injectable Solution
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
SML05
Device description
Product is sky-blue viscous liquid, the content is 5ml. Initial packaging is the syringe.
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
PLLSubmucosal Injection Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLLSubmucosal Injection AgentGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200071000Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.2020-11-03PLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503562512PackageGS112In Commercial Distribution
26932503562519PackageGS19In Commercial Distribution
06932503562515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250356251216932503562512
2693250356251926932503562519
06932503562515069325035625156932503562515

GMDN Terms#

Term, Definition table
TermDefinition
Injectable charcoal tattoo markerAn implantable suspension of charcoal intended to be injected subcutaneously (e.g., under ultrasound imaging) to mark the skin over the site of a lump/lesion, or into deeper tissues to provide a visual mark for subsequent surgical excision. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Contacts#

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

Regulatory Flags#

DUNS number
530269083
Device count
1
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
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
06932503575409Sphincterotome / short-wire compatibleRDSP-0220-2212026-05-08
06932503575416Sphincterotome / short-wire compatibleRDSP-0220-1312026-05-08
06932503575423Sphincterotome / short-wire compatibleRDSP-0220-2312026-05-08
06932503575430Sphincterotome / short-wire compatibleRDSP-0225-1112026-05-08
06932503575447Sphincterotome / short-wire compatibleRDSP-0225-2112026-05-08
06932503575454Sphincterotome / short-wire compatibleRDSP-0225-1212026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995231866ASCENDO submucosal lifting agentUS EndoscopyPLL2024-09-02
10724995231863ASCENDO submucosal lifting agentTHE STANDARD CO.,LTD.PLL2024-09-02
08809380057473Blue EyeTHE STANDARD CO.,LTD.PLL2024-08-16
08809380057480Blue EyeThe Standard Co., Ltd.PLL2024-08-16
08809380050207Blue EyeTHE STANDARD CO.,LTD.PLL2023-07-19
08809380050214Blue EyeThe Standard Co., Ltd.PLL2023-07-19
00724995221614AscendoUS EndoscopyPLL2023-07-11
20724995221618AscendoUS EndoscopyPLL2023-07-11
06932503562522BlueBoost(TM) Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.PLL2023-06-28
16932503562512MTMicro-Tech (Nanjing) Co., Ltd.PLL2023-06-28
16932503562529MTMicro-Tech (Nanjing) Co., Ltd.PLL2023-06-28
04260206311003LiftUpOvesco Endoscopy AGPLL2022-08-22
04260206310990LiftUpOvesco Endoscopy AGPLL2022-08-22
04260206311355LiftUp KitOvesco Endoscopy AGPLL2022-08-22
05391530190466Eleview 5mLCOSMO TECHNOLOGIES LIMITEDPLL2022-04-01
05391530190459Eleview 5mLCOSMO TECHNOLOGIES LIMITEDPLL2022-04-01
16972011720240EndoClot SISEndoClot Plus Co.,Ltd.PLL2021-11-16
16972011720257EndoClot SISEndoClot Plus Co.,Ltd.PLL2021-11-16
26972011720247EndoClot SISEndoClot Plus Co.,Ltd.PLL2021-11-16
26972011720254EndoClot SISEndoClot Plus Co.,Ltd.PLL2021-11-16
16972011720226EndoClot EndoClot Plus Co.,Ltd.PLL2021-06-23
26972011720223EndoClot EndoClot Plus Co.,Ltd.PLL2021-06-23
05391530190367EleviewCOSMO TECHNOLOGIES LIMITEDPLL2021-03-28
05391530190008EleviewCOSMO TECHNOLOGIES LIMITEDPLL2021-03-28
00893029002243EverLiftGI Supply, Inc.PLL2021-02-18
00893029002229EverLiftGI Supply, Inc.PLL2021-02-18
10893029002240EverLiftGI Supply, Inc.PLL2021-02-18
16972011720219EndoClot EndoClot Plus Co.,Ltd.PLL2021-02-10
26972011720216EndoClot EndoClot Plus Co.,Ltd.PLL2021-02-10
05391530190053EleviewCOSMO TECHNOLOGIES LIMITEDPLL2019-12-19