AccessGUDID - DEVICE: SPiN Xtend 2.0mm OD, 21ga (00815686020651)

GUDID

Device Identifier (DI) Information

Brand Name: SPiN Xtend 2.0mm OD, 21ga
Version or Model: INS-5450
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: INS-5450
Company Name: VERAN MEDICAL TECHNOLOGIES INC.

Primary DI Number: 00815686020651
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 181714804 *Terms of Use

Device Description: No description.

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":	No
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?
46678	Flexible endoscopic biopsy handpiece/needle	A sterile flexible device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122106	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: 23a722c3-1790-4fb2-abbc-a3e04ea4646f
Public Version Date: February 16, 2024
Public Version Number: 5
DI Record Publish Date: August 31, 2016