AccessGUDID - DEVICE: Duckworth & Kent (05055313822646)

GUDID

Device Identifier (DI) Information

Brand Name: Duckworth & Kent
Version or Model: 1-841N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1-841N
Company Name: DUCKWORTH AND KENT LIMITED

Primary DI Number: 05055313822646
Issuing Agency: GS1
Commercial Distribution End Date: March 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 217182583 *Terms of Use

Device Description: Vitreoretinal Scissors Head

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?
63555	Intraocular scissors probe-tip, reusable	A distal component of a probe-like intraocular scissors assembly intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). It is a probe-/cannula-like shaft with two shearing blades at the end, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). It is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNF	Scissors, 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: e8a3275f-73b8-4b9c-a048-277ee53f76f4
Public Version Date: April 05, 2023
Public Version Number: 2
DI Record Publish Date: August 31, 2022