FDA.reportPublic FDA data

MT

Primary DI
16932503530450
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
ROCC-F-26-165-C-N
Device description
Open width16±2mm the max OD of insertion part 2.6mm working length 1650mm coated, Full Rotation wire
Published
2021-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182556000SureClip Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.2018-12-14PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503530450PackageGS110In Commercial Distribution
26932503530457PackageGS110In Commercial Distribution
56932503530458PackageGS12In Commercial Distribution
66932503530455PackageGS125In Commercial Distribution
06932503530453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250353045016932503530450
2693250353045726932503530457
5693250353045856932503530458
6693250353045566932503530455
06932503530453069325035304536932503530453

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, long-term, non-bioabsorbableA non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length165Centimeter
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
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664913482NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915387NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915394NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915400NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915417NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915424NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915431NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915448NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915455NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915462NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915479NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915493NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915509NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915516NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915523NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915530NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915547NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915554NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915561NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915578NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915592NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915615NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915622NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915639NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915646NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915653NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915660NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915677NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915684NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915691NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16