FDA.reportPublic FDA data

MT

Primary DI
16932503562772
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
MT-RGL-P-N
Device description
The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.
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

Product Codes#

Code, Name table
CodeName
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220247000Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd.2022-03-29ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503562772PackageGS110In Commercial Distribution
26932503562779PackageGS110In Commercial Distribution
06932503562775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250356277216932503562772
2693250356277926932503562779
06932503562775069325035627756932503562775

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic guidewire holderA device intended to be used during diagnostic and/or therapeutic endoscopy of the gastrointestinal (GI) tract [e.g., endoscopic retrograde cholangiopancreatography (ERCP)] to hold a guidewire in place at a given insertion depth through the working channel of an endoscope. It is typically a small plastic device intended to be attached to the proximal end of the endoscope, with a feature to hold the guidewire in place (e.g., j-slot). This is a single-use device.

Sterilization Methods#

Method table
Method

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
16932503514658Biliary Plastic Stent SetBPDS-41114-0712/172026-03-20
16932503515617Biliary Plastic Stent SetBPDS-41114-0715/172026-03-20
16932503515624Biliary Plastic Stent SetBPDS-41114-0718/172026-03-20
16932503515631Biliary Plastic Stent SetBPDS-41114-0805/222026-03-20
16932503515648Biliary Plastic Stent SetBPDS-41114-0807/222026-03-20
16932503515655Biliary Plastic Stent SetBPDS-41114-0809/222026-03-20
16932503515662Biliary Plastic Stent SetBPDS-41114-0812/222026-03-20
16932503515679Biliary Plastic Stent SetBPDS-41114-0815/222026-03-20
16932503515686Biliary Plastic Stent SetBPDS-41114-0818/222026-03-20
16932503515693Biliary Plastic Stent SetBPDS-41114-1005/222026-03-20
16932503515709Biliary Plastic Stent SetBPDS-41114-1007/222026-03-20
16932503515716Biliary Plastic Stent SetBPDS-41114-1009/222026-03-20
16932503515723Biliary Plastic Stent SetBPDS-41114-1012/222026-03-20
16932503515730Biliary Plastic Stent SetBPDS-41114-1015/222026-03-20
16932503515747Biliary Plastic Stent SetBPDS-41114-1018/222026-03-20
16932503515754Biliary Plastic Stent SetBPDS-41114-1105/222026-03-20
16932503515761Biliary Plastic Stent SetBPDS-41114-1107/222026-03-20
16932503515778Biliary Plastic Stent SetBPDS-41114-1109/222026-03-20
16932503515785Biliary Plastic Stent SetBPDS-41114-1112/222026-03-20
16932503515792Biliary Plastic Stent SetBPDS-41114-1115/222026-03-20

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