AccessGUDID - DEVICE: RiteClip(TM) Repositionable Hemostasis Clip (06932503530682)

GUDID

Device Identifier (DI) Information

Brand Name: RiteClip(TM) Repositionable Hemostasis Clip
Version or Model: ROCC-C-26-165-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503530682
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Open width8+2/0mm the max OD of insertion part 2.6mm working length 1650mm 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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61207	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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161463	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 165 Centimeter
Outer Diameter: 2.6 Millimeter

Device Record Status

Public Device Record Key: 3908e071-34f6-41ae-a8c7-de214b328c8b
Public Version Date: October 11, 2024
Public Version Number: 3
DI Record Publish Date: June 28, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
16932503530689	10	06932503530682	In Commercial Distribution	BOX
26932503530686	10	16932503530689	In Commercial Distribution	CASE
56932503530687	2	06932503530682	In Commercial Distribution	BOX
66932503530684	25	56932503530687	In Commercial Distribution	CASE