AccessGUDID - DEVICE: Duckworth & Kent (05055313827252)

GUDID

Device Identifier (DI) Information

Brand Name: Duckworth & Kent
Version or Model: 6-194-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6-194-2
Company Name: DUCKWORTH AND KENT LIMITED

Primary DI Number: 05055313827252
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 217182583 *Terms of Use

Device Description: Shuttle

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?
63624	Scleral expansion implant implantation tool	A non-powered, ophthalmic surgical device intended to be used for implantation of a scleral expansion implant (not included). It is typically a blunt dilator-like rod designed to accept the scleral expansion implant at its proximal end and then threaded through a prepared sub-scleral tunnel whereupon the implant is deployed. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNM	Needle, Ophthalmic Suturing

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: 458770a0-8839-46c7-b0cc-f43603ad9d0b
Public Version Date: September 08, 2022
Public Version Number: 1
DI Record Publish Date: August 31, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +441462893254
Email: info@duckworth-and-kent.co.uk

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