AccessGUDID - DEVICE: Key Surgical Needle Counters (00849771030508)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Needle Counters
Version or Model: NC-10-100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NC10100
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771030508
Issuing Agency: GS1
Commercial Distribution End Date: March 05, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Needle Counters, Sterile, 10 Count, Magnetic, Clear Lid, 50 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?
61634	Sharp surgical instrument counting tray/pad, single-use	A device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAB	Needle, Suturing, Disposable

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: f0fe03a8-8f21-4ad1-b2a2-ce680cd32ccf
Public Version Date: March 06, 2025
Public Version Number: 4
DI Record Publish Date: December 09, 2020