AccessGUDID - DEVICE: 20ga Dex™ Vertical Scissors (00817489022481)

GUDID

Device Identifier (DI) Information

Brand Name: 20ga Dex™ Vertical Scissors
Version or Model: DVS5101-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KATALYST SURGICAL LLC

Primary DI Number: 00817489022481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007883297 *Terms of Use

Device Description: Box of 5, 20ga Dex™ Vertical 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:	Yes
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?
46726	Anterior/posterior segment scissors, single-use	An ophthalmic surgical instrument designed to cut either anterior or posterior segment tissue during eye surgery. It is typically: 1) two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed); or 2) an instrument tip, with cutting blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a single-use device.	Obsolete	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 08380b66-2e70-43a2-bdcd-6603da9ba5e8
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 11, 2016

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: No
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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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