FDA.reportPublic FDA data

MT

Primary DI
16932503563014
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
ETS00001
Device description
ETD-C-26-165-C-N,ROCC-00001
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QSWEndoscopic Traction Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSWEndoscopic Traction DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222354000Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.2022-10-03QSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503563014PackageGS11In Commercial Distribution
26932503563011PackageGS125In Commercial Distribution
06932503563017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250356301416932503563014
2693250356301126932503563011
06932503563017069325035630176932503563017

GMDN Terms#

Term, Definition table
TermDefinition
Endoluminal self-retaining endoscopic retractorA sterile self-retaining retraction device intended to be used during endoscopic gastrointestinal surgery to improve dissection and submucosal visualization, by providing tension by attachment to the area to be dissected and to the opposing wall within the gut lumen. The tether consists of an elastic stem with a clip at either end for attachment to the mucosa, and is supplied with dedicated grasping forceps and flexible catheter for delivery/positioning of the retractor. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1650Millimeter
Outer Diameter2.6Millimeter

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
06932503563017SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563024SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563031SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563048SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563055SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563062SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563079SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563086SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563093SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563109SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563116SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563123SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563130SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
06932503563147SureTrac(TM) Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563021MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563038MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563045MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563052MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563069MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563076MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563083MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563090MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563106MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563113MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563120MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563137MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
16932503563144MTMicro-Tech (Nanjing) Co., Ltd.QSW2023-06-28
10884521808393ProdiGICovidien LPQSW2022-07-15
10884521808409ProdiGICovidien LPQSW2022-07-15
20884521808390ProdiGICovidien LPQSW2022-07-15