AccessGUDID - DEVICE: Knee Immobilizer S/A, Super-Lite, 28" (00609271611481)

GUDID

Device Identifier (DI) Information

Brand Name: Knee Immobilizer S/A, Super-Lite, 28"
Version or Model: E62651
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E62651
Company Name: DARCO INTERNATIONAL, INC.

Primary DI Number: 00609271611481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184231298 *Terms of Use

Device Description: No description.

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?
12099	Knee immobilizer	A rigid external support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITQ	JOINT, KNEE, EXTERNAL BRACE

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: 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: e90a9cdf-2d47-47c4-80cc-646f2cb6f872
Public Version Date: July 25, 2024
Public Version Number: 2
DI Record Publish Date: February 08, 2023