AccessGUDID - DEVICE: SerosaFuse® Implantable Fastener Kit (00810275014011)

GUDID

Device Identifier (DI) Information

Brand Name: SerosaFuse® Implantable Fastener Kit
Version or Model: R2275
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R2275
Company Name: ENDOGASTRIC SOLUTIONS, INC.

Primary DI Number: 00810275014011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 143602659 *Terms of Use

Device Description: Single kit consists of 1 each R2007 EsophyX Z+ Fastener Delivery Device and 1 each R2375 SerosaFuse Implantable Fastener Cartridge

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
37390	Endoscopic suturing unit, single-use	A sterile, manually-operated device intended to be used in combination with a compatible flexible endoscope (e.g., gastroscope, laparoscope) to mechanically approximate the edges of an internal wound or incision with sutures, typically during a gastrointestinal (GI) procedure. It is typically loaded with a needle/suture assembly and attached to the working end, or inserted through the working channel, of the endoscope. The device will also knot and cut the sutures as they are stitched; some types may also carry and/or knot a ligature. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ODE	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

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
No Device Sizes

Device Record Status

Public Device Record Key: f4dcdac8-518e-49de-9755-cffba5c87e1a
Public Version Date: March 22, 2019
Public Version Number: 1
DI Record Publish Date: March 14, 2019