Key Surgical Sterile Labels

Basic Information

• Brand Name: Key Surgical Sterile Labels
• Primary DI: 00849771032946
• Version / Model: SL-107
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-12-21
• Public Version: 3
• Public Version Date: 2021-09-08
• Public Version Status: Update
• Public Device Record Key: ba76d4b4-da65-42a3-aaad-aee217ef3c3a

Device Description

Sterile Labels - Custom, 10 labels/panel, 1 panel/pouch, 100 pouches/Box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYV	Label Or Tag, Sterile	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00849771032953	GS1	Box	100	In Commercial Distribution
Primary	00849771032946	GS1
Unit of Use	00849771044000	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]