FDA.reportPublic FDA data

Tracheal Stent system (Y-shaped)

Primary DI
06932503581837
Brand
Tracheal Stent system (Y-shaped)
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
NST02-962-20.060-110
Device description
Y-shaped, main body20×60,one branch14×35, the other branch14×15, Partially Covered, Delivery System 8×650
Published
2023-02-03
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
K212403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212403000Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd.2021-10-30JCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932503581837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932503581837069325035818376932503581837

GMDN Terms#

Term, Definition table
TermDefinition
Polymer-metal tracheal/bronchial stentA non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body with metallic support structures), and may have a straight or branched configuration. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Stent Diameter20Millimeter
Stent Length60Millimeter

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
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

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