AccessGUDID - DEVICE: Instrument Stringers (00849771038290)

GUDID

Device Identifier (DI) Information

Brand Name: Instrument Stringers
Version or Model: IS-55514
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771038290
Issuing Agency: GS1
Commercial Distribution End Date: January 18, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: U-Shaped Instrument Stringer, 14-inch x 5.5-inch

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?
64168	Sterilization stringer	A device designed to hang hinged, ring-handled surgical instruments (e.g. forceps, scissors) in an open position during sterilization. Often referred to as an instrument stringer, it is typically in the form of a U-/D-shaped locking bar. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 5.5 Inch

Device Record Status

Public Device Record Key: 820a0bcf-5f01-44b6-8b2b-660db6f00c93
Public Version Date: January 24, 2023
Public Version Number: 4
DI Record Publish Date: April 16, 2021