FDA.reportPublic FDA data

Endocuff

Primary DI
05060423410089
Brand
Endocuff
Company
BODDINGTONS PLASTICS LIMITED
Model
AEC110
Device description
AEC110 Size 1 (M) Endocuff Sterile Blue - 1 pot - single unit
Published
2016-08-08
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

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
K122565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122565000ARC ENDOCUFFBoddingtons Plastics, Ltd.2012-09-04FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
5060423410003PackageGS18In Commercial Distribution
5060423410126PackageGS1120In Commercial Distribution
05060423410089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5060423410003050604234100035060423410003
5060423410126050604234101265060423410126
05060423410089050604234100895060423410089

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter11Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
216745893
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060423410164Endocuff VisionARV1102016-08-08
05060423410171Endocuff VisionARV1202016-08-08
05060423410188Endocuff VisionARV1302016-08-09
05060423410195Endocuff VisionARV1402016-08-09
05060423410249Endocuff Vision ARV110U2017-01-20
05060423410256Endocuff VisionARV120U2017-01-20
05060423410263Endocuff VisionARV130U2017-01-23
05060423410270Endocuff VisionARV140U2017-01-23
05060423410096EndocuffAEC1202016-08-08
05060423410102EndocuffAEC1302016-08-08
05060423410119EndocuffAEC1402016-08-08
05060423410324Endocuff Vision ARV110U2017-01-20
05060423410393WIDE-EYE MultitrapAPT0062016-11-15
05060423410539WIDE-EYE PolyptrapAPT0132018-10-16
05060423410560WIDE-EYE PolyptrapAPT013U2018-10-16
05060423410911Non-sterile specimen mailer and storage container PE 50 StandardPE50 Standard2023-05-25
05060423410935Peezy Non-sterile specimen mailer and storage container PE 51 BoricPE 51 Boric2023-05-09
05060423410959Peezy Non-sterile specimen mailer and storage container PE 51 BoricPE 51 Boric2023-05-09
05060423410690Non-sterile specimen mailer and storage container PE 50 Standard PE 50 2023-05-25
05060423410362WIDE-EYE PolyptrapAPT0052016-11-15

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