AccessGUDID - DEVICE: Single Use Repositionable Clip (04953170385933)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use Repositionable Clip
Version or Model: HX-202UR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170385933
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: No description.

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?
35649	Ligation clip, metallic	A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.	Active	true

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 [?]
K123601	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
No Device Sizes

Device Record Status

Public Device Record Key: 5782690d-a16e-44a0-b89b-1ccfed77a2c4
Public Version Date: April 22, 2024
Public Version Number: 6
DI Record Publish Date: September 21, 2016