Endocuff

GUDID 05060423410102

AEC130 Size 3 (S) Endocuff Sterile Purple- 1 pot - single unit

BODDINGTONS PLASTICS LIMITED

Colonic endoscopy cuff
Primary Device ID05060423410102
NIH Device Record Keyb4a8620d-07a1-4850-8568-ebe7d68b6fb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndocuff
Version Model NumberAEC130
Company DUNS216745893
Company NameBODDINGTONS PLASTICS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter
Lumen/Inner Diameter10.4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105060423410102 [Primary]
GS15060423410027 [Package]
Package: Carton [8 Units]
In Commercial Distribution
GS15060423410140 [Package]
Contains: 5060423410027
Package: Shipper [120 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEDEndoscopic Access Overtube, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-08

On-Brand Devices [Endocuff]

05060423410119AEC140 Size 4 (Xl) Endocuff Sterile Orange- 1 pot - single unit
05060423410102AEC130 Size 3 (S) Endocuff Sterile Purple- 1 pot - single unit
05060423410096AEC120 Size 2 (L) Endocuff Sterile Green- 1 pot - single unit
05060423410089AEC110 Size 1 (M) Endocuff Sterile Blue - 1 pot - single unit

Trademark Results [Endocuff]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDOCUFF
ENDOCUFF
79120509 4492954 Live/Registered
ARC Medical Design Limited
2012-09-07
ENDOCUFF
ENDOCUFF
76220865 not registered Dead/Abandoned
Advanced Surgical Concepts Limited
2001-03-05

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