AccessGUDID - DEVICE: Key Surgical Plastic Instruments (00849771027072)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Plastic Instruments
Version or Model: KS-348-50
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KS34850
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771027072
Issuing Agency: GS1
Commercial Distribution End Date: April 24, 2023
Device Count: 50
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Plastic Instruments, Angled Towel Clamp, oblong tip, 4.75-inch, light green

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?
34961	Towel clamp, reusable	A surgical instrument designed to hold together surgical towels and/or drapes, or for securing other devices such as cables/leads, during an operation/intervention. It is made of metallic or polymer materials and is available in a variety of sizes and designs (e.g., two blades joined at their midpoints, single alpha-shaped device, various gripping jaws); it is commonly known as a towel clamp, towel forceps, or towel clip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXD	Clamp

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

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: d19c8bf6-8bae-4d23-9041-de95e5ac4d75
Public Version Date: April 25, 2023
Public Version Number: 6
DI Record Publish Date: December 21, 2020