FDA.reportPublic FDA data

MT

Primary DI
16932503562222
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
WP-18/1600
Device description
Blue handle 1.8mm OD 1600mm length
Published
2021-12-31
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
GCEAdaptor, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCEAdaptor, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503562222PackageGS120In Commercial Distribution
26932503562229PackageGS110In Commercial Distribution
06932503562225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250356222216932503562222
2693250356222926932503562229
06932503562225069325035622256932503562225

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic spray catheter, single-useA flexible tube intended to be used with an endoscope (e.g., colonoscope) to administer fluids (e.g., dyes for mucosal colouration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length160Centimeter
Outer Diameter1.8Millimeter

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
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04044503008145FUJIFILM medworkFUJIFILM medwork GmbHGCE2026-03-31
06932503562256Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2025-04-30
16932503562253Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2025-04-30
00850052377007CLR Port InjectorCLR MedicalGCE2024-05-29
00860003054918CLR PortCLR MedicalGCE2024-05-29
00860003054994CLR Port CapCLR MedicalGCE2024-05-29
00850052377021CLR Port InjectorCLR MedicalGCE2024-05-29
00860003054956CLR PortCLR MedicalGCE2024-05-29
00850052377014CLR Port CapCLR MedicalGCE2024-05-29
00887709078017ICU MedicalICU MEDICAL, INC.GCE2023-08-30
00887709078024ICU MedicalICU MEDICAL, INC.GCE2023-08-30
10887709078014ICU MedicalICU MEDICAL, INC.GCE2023-08-30
10887709078021ICU MedicalICU MEDICAL, INC.GCE2023-08-30
00827002226760COOKCOOK INCORPORATEDGCE2022-12-08
00827002226777COOKCOOK INCORPORATEDGCE2022-12-08
M7525250520STRADIS HEALTHCARESTRADIS MEDICAL, LLCGCE2022-03-09
06932503562218Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562225Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562232Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562249Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562263Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562270Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562287Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562294Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562300Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562215MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562239MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562246MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562260MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562277MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31