AccessGUDID - DEVICE: Duckworth & Kent (05055313801719)

GUDID

Device Identifier (DI) Information

Brand Name: Duckworth & Kent
Version or Model: 2-195-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2-195-1
Company Name: DUCKWORTH AND KENT LIMITED

Primary DI Number: 05055313801719
Issuing Agency: GS1
Commercial Distribution End Date: October 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 217182583 *Terms of Use

Device Description: Cilia Forceps

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?
63485	Cilia forceps	A dedicated, hand-held, manual, surgical instrument designed to facilitate the grasping and removal of the cilia (eyelashes). It has a tweezers-like design with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is typically made of metal, available in various sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNR	Forceps, Ophthalmic

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: 6bfea2e3-685f-4826-9fab-387be7f7d961
Public Version Date: October 06, 2022
Public Version Number: 3
DI Record Publish Date: August 31, 2022