AccessGUDID - DEVICE: SureClip (06932503530224)

GUDID

Device Identifier (DI) Information

Brand Name: SureClip
Version or Model: ROCC-C-26-235-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ROCC-C-26-235-C
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503530224
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Open width8±1mm the max OD of insertion part 2.6mm working length 2350mm coated

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Gastrointestinal endoscopic clip, short-term	A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
PKL	Hemostatic Metal Clip For The Gi Tract

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152001	000

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9b68c7ff-1c46-4d5b-8734-a194ec710b35
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 10, 2016