FDA.reportPublic FDA data

Endo-Ease Discovery Standard Profile

Primary DI
00867630000226
Brand
Endo-Ease Discovery Standard Profile
Company
SPIRUS MEDICAL LLC
Model
EED-300
Catalog number
EED-300
Device description
Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K080050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080050000SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBESpirus Medical, Inc.2008-05-06FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30867630000203PackageGS14In Commercial Distribution
00867630000226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3086763000020330867630000203
00867630000226008676300002268676300002260867630000226

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic overtube, single-useA tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-584-1596ejohnson@primomedicalgroup.com

Regulatory Flags#

DUNS number
969696975
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867630000202Endo-Ease Vista RetrogradeEEV-200EEV-2002016-09-23
00867630000219Endo-Ease Discovery Low ProfileEED-250EED-2502016-09-23
00867630000233Endo-Ease LubricantEEL-400EEL-4002016-09-23

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Primary DI, Brand, Company table
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