AccessGUDID - DEVICE: SureClip (06932503530224)

GUDID

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

Primary DI Number: 06932503530224
Issuing Agency: GS1
Device Count: 1

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

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 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.

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

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
No storage/handling found

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: March 10, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
26932503530228	10	16932503530221		In Commercial Distribution	10
16932503530221	10	06932503530224		In Commercial Distribution	10

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

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

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

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

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