FDA.reportPublic FDA data

Embrella(TM) Endoscopic Distal Attachment

Primary DI
06932503560825
Brand
Embrella(TM) Endoscopic Distal Attachment
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
EM-S-01
Device description
The endoscope with a diameter of 12.8-14.5mm is available. The product is standard type of Embrella™ Endoscopic Distal Attachment .
Published
2021-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
16932503560822PackageGS110In Commercial Distribution
26932503560829PackageGS110In Commercial Distribution
06932503560825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250356082216932503560822
2693250356082926932503560829
06932503560825069325035608256932503560825

GMDN Terms#

Term, Definition table
TermDefinition
Colonoscope distal anchoring cuffA device in the form of a cuff with concentric finger-like components intended to fit to a flexible colonoscope distal end to stabilize its tip within the colonic lumen and straighten the colonic folds to facilitate observation and/or surgical instrument use. The fingers are intended to open and grip the colon during pull back (exturbation); the device may in addition have a protruding distal end (spacer) intended to maintain distance between the endoscope tip and structures of interest. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
877-552-4027info@micro-tech-usa.com

Regulatory Flags#

DUNS number
530269083
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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06932503575393Sphincterotome / short-wire compatibleRDSP-0220-1212026-05-08

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