AccessGUDID - DEVICE: AROSurgical Vein Vascular Clamp (10818245020007)

GUDID

Device Identifier (DI) Information

Brand Name: AROSurgical Vein Vascular Clamp
Version or Model: TKF-1-15g
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TKF-1-15g
Company Name: AROS SURGICAL INSTRUMENTS CORPORATION

Primary DI Number: 10818245020007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 883777989 *Terms of Use

Device Description: Vein Clamps Single Supra Small, Green, 15g, Box/10

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?
61143	Suturing needle, single-use	A cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	CLAMP, VASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: Closing Pressure 15 grams
Length: 11 Millimeter

Device Record Status

Public Device Record Key: e1df42cb-d9d3-4354-be6c-8458529f7a10
Public Version Date: December 04, 2020
Public Version Number: 3
DI Record Publish Date: November 18, 2016