AccessGUDID - DEVICE: FasTouch™ (07290017155043)

GUDID

Device Identifier (DI) Information

Brand Name: FasTouch™
Version or Model: SFTPC10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SFTPC10
Company Name: VIA SURGICAL LTD

Primary DI Number: 07290017155043
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600319250 *Terms of Use

Device Description: Sterile Sample of the FasTouch™ Permanent Reloadable Cartridge 10 Permanent Fasteners

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
59874	Endoscopic manual linear stapler	A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue during a laparoscopic procedure; it has no cutting function and may be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDW	Staple, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162252	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: 37 Centimeter
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: cad3507d-f451-49ea-a44d-552462f87326
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 29, 2017