AccessGUDID - DEVICE: Endocuff (05060423410096)

GUDID

Device Identifier (DI) Information

Brand Name: Endocuff
Version or Model: AEC120
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BODDINGTONS PLASTICS LIMITED

Primary DI Number: 05060423410096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216745893 *Terms of Use

Device Description: AEC120 Size 2 (L) Endocuff Sterile Green- 1 pot - single unit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60911	Colonic endoscopy cuff	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FED	Endoscopic Access Overtube, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 11.2 Millimeter

Device Record Status

Public Device Record Key: 4b62fc06-2cce-4d34-a557-a4474dd27e62
Public Version Date: February 21, 2024
Public Version Number: 5
DI Record Publish Date: August 08, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
5060423410010	8	05060423410096		In Commercial Distribution	Carton
5060423410133	120	5060423410010		In Commercial Distribution	Shipper

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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