AccessGUDID - DEVICE: NA (00724995158064)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: BF717
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BF717
Company Name: STERIS CORPORATION

Primary DI Number: 00724995158064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The Arthroscopy Knee Holder with pad set attaches to the seat section of the table with a Clark Socket (not included) and is typically used for the off the end of the table arthroscopy technique.

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):	Yes
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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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: 2087825a-e5e5-4e66-97e9-2a2baf38afe9
Public Version Date: July 25, 2024
Public Version Number: 2
DI Record Publish Date: April 23, 2021