AccessGUDID - DEVICE: Duckworth & Kent (05055313814481)

GUDID

Device Identifier (DI) Information

Brand Name: Duckworth & Kent
Version or Model: 9-687-4
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9-687-4
Company Name: DUCKWORTH AND KENT LIMITED

Primary DI Number: 05055313814481
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: Incision Gauge

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?
63538	Ophthalmic surgical incision gauge	A manual surgical instrument intended to be used during an ophthalmic surgical procedure to measure the length of an incision made on the surface of the eye (cornea or sclera). It typically consists of a hand-held metal tool with graduations. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOE	Caliper, 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: 482a2f29-6169-465a-9f15-ee06a5e65950
Public Version Date: December 15, 2023
Public Version Number: 2
DI Record Publish Date: August 31, 2022