AccessGUDID - DEVICE: NA (07613327058666)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0250080701
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0250-080-701
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327058666
Issuing Agency: GS1
Commercial Distribution End Date: February 15, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Endoloop Applicator

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:	No
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?
34078	Endoscopic suturing unit, reusable	A 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 reusable device intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OCZ	Endoscopic grasping/cutting instrument, non-powered

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5.0 Millimeter

Device Record Status

Public Device Record Key: 94b083d9-8011-41cd-b1ef-1e0df3acc173
Public Version Date: February 15, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016