FDA.reportPublic FDA data

Through the Scope Tracheal Stent System

Primary DI
06932503581561
Brand
Through the Scope Tracheal Stent System
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
NST12-334-14.020
Device description
Double spherical 14×20 mm, Covered ,2.7*1200
Published
2023-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCTProsthesis, Tracheal, Expandable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCTProsthesis, Tracheal, ExpandableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220424000Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.2022-07-08JCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932503581561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932503581561069325035815616932503581561

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Stent Diameter14Millimeter
Stent Length20Millimeter

Sterilization Methods#

Method table
Method

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
06932503563857Additional Working ChannelEZS011752026-09-30
06932503563864Additional Working ChannelEZS114752026-09-30
06932503563871Additional Working ChannelEZS217802026-09-30
06932503516563Sphincterotome / short-wire compatibleRDSP-0230-231-22026-06-27
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

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