AccessGUDID - DEVICE: Single Use Surgical Professional (05055299101414)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use Surgical Professional
Version or Model: S098
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S098
Company Name: EAKIN SURGICAL LIMITED

Primary DI Number: 05055299101414
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 239505063 *Terms of Use

Device Description: Mosquito Forceps Curved Set of 2

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:	Yes
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?
65449	ENT foreign body extraction forceps	A hand-held, manual, non-surgical device intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure; it is not intended for surgical grasping or manipulation of tissues. It is a rod with small jaws at its distal end which are controlled by pressing its handle; it may also include a magnifying lens and/or light source. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEN	Forceps, General & Plastic Surgery

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: 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: bcd8831f-a1e4-418d-a737-7feac97c70c8
Public Version Date: October 25, 2023
Public Version Number: 4
DI Record Publish Date: August 09, 2016