FDA.reportPublic FDA data

MT

Primary DI
16932503560815
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
EM-S-02
Device description
The endoscope with a diameter of 11.5-13mm is available. The product is standard type of Embrella™ Endoscopic Distal Attachment .
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
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190030000Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd.2019-03-05FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503560815PackageGS110In Commercial Distribution
26932503560812PackageGS110In Commercial Distribution
06932503560818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250356081516932503560815
2693250356081226932503560812
06932503560818069325035608186932503560818

GMDN Terms#

Term, Definition table
TermDefinition
Colonic endoscopy cuffA sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy. It is in the form of a polymer cuff with retractable concentric fingers intended to open and grip the colon during pull back (exturbation) to straighten colonic folds and centralize the endoscope within the lumen; it is not intended to hinder intubation. This is a single-use device.

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
00191506062514Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062576Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
06942804744602Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744619Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744626Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744633Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744640Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744657Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744664Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744671Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744688Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744695Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744701Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744718Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744725Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744732Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744749Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744756Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744763Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744770Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744787Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744794Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744800Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22