AccessGUDID - DEVICE: EsophyX Z (00810275011072)

GUDID

Device Identifier (DI) Information

Brand Name: EsophyX Z
Version or Model: R2006
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENDOGASTRIC SOLUTIONS, INC.

Primary DI Number: 00810275011072
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 143602659 *Terms of Use

Device Description: EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories

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:	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?
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 [?]
K143645	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: c466f37b-5354-4b35-be55-20be017b645b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 425-307-9269
Email: customerservice@endogastricsolutions.com

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