AccessGUDID - DEVICE: Duckworth & Kent (05055313800538)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 05055313800538
Issuing Agency: GS1
Commercial Distribution End Date: November 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 217182583 *Terms of Use

Device Description: Vitreoretinal Scissors

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?
63486	Intraocular scissors, probe-like, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). As a complete instrument it comprises two shearing blades at the end of a probe-/cannula-like shaft with a proximal slimline handle, typically operated by squeezing. 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: 6b5fa925-48bd-423e-89bc-bb7ebf82e624
Public Version Date: December 15, 2023
Public Version Number: 2
DI Record Publish Date: August 31, 2022