AccessGUDID - DEVICE: LARGE UNI-CLIP® (10381780044680)

GUDID

Device Identifier (DI) Information

Brand Name: LARGE UNI-CLIP®
Version or Model: 119314ND
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NEWDEAL

Primary DI Number: 10381780044680
Issuing Agency: GS1
Commercial Distribution End Date: October 22, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The spreading forceps is used to generate compression to achieve fixation. Placed in the diamond of the staple, by squeezing the diamond will expand and the staple legs will come together in a parallel manner.

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":	Yes
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?
44539	Surgical flat-nosed pliers	A heavy-duty, surgical instrument with specially designed sturdy handles and gripping jaws (typically parallel) used to grip and hold an object during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTD	FORCEPS

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: ee86c40c-e316-4a58-9cae-db254b3e7ee5
Public Version Date: March 19, 2019
Public Version Number: 3
DI Record Publish Date: May 26, 2017