AccessGUDID - DEVICE: Mediflex Laparoscopic Instruments - Suture Grasper Guides (00842102112355)

GUDID

Device Identifier (DI) Information

Brand Name: Mediflex Laparoscopic Instruments - Suture Grasper Guides
Version or Model: 94425
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FLEXBAR MACHINE CORPORATION

Primary DI Number: 00842102112355
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047644935 *Terms of Use

Device Description: Suture Passer Guide 15mm x 9.6cm

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):	No
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?
36129	Suturing guide	A surgical device that is placed over an open wound to the aid the surgeon in placing the sutures so that, when pulled tight, the sutures will meet. It is typically made of metal or plastic material. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, Surgical, Instrument

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: af0a5727-0244-449b-bc28-c213e8d40688
Public Version Date: March 04, 2019
Public Version Number: 1
DI Record Publish Date: January 31, 2019