AccessGUDID - DEVICE: NA (10849771050756)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Sterile Labels
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SL211
Company Name: KEY SURGICAL, INC.

Primary DI Number: 10849771050756
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 604056226 *Terms of Use
Previous DI: 00849771033257

Device Description: Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 packages per box

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?
47731	Procedural medication labelling set	A collection of devices intended to provide clinical staff with a standardized method to label medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions in and outside of the sterile field in perioperative and other procedural settings. It typically includes a permanent marking pen and various labels typically made of moisture resistant plastic material and provided with standard medication/drug/solution text (e.g., lidocaine, heparin, morphine sulfate, saline, sterile water) which can be further qualified using the pen; the labels may also include additional text fields (e.g., for date, initials). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYV	LABEL OR TAG, STERILE

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: 774eb57e-4d43-4387-b97b-a76de88cde43
Public Version Date: May 08, 2023
Public Version Number: 2
DI Record Publish Date: April 24, 2023