AccessGUDID - DEVICE: Light Weight Leg Transfer Board, Sling Style (00863106000462)

GUDID

Device Identifier (DI) Information

Brand Name: Light Weight Leg Transfer Board, Sling Style
Version or Model: OZ 7560175
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: P AND G ENGINEERING INC

Primary DI Number: 00863106000462
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 795690242 *Terms of Use

Device Description: Light Weight Leg Transfer Board, Sling Style, OZ 7560175

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?
37256	Urological operating table top	A component of a modular operating table designed as a detachable table top to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. Its surface consists of a flat section that may have motor-driven longitudinal traverse, a headrest, adjustable leg holders and facilitate a urine/irrigation fluid collection tray with a filter to catch urinary stones/fragments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FWZ	Operating Room Accessories Table Tray

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: e5d3be06-0fce-4f99-90d9-89e9c2a6920b
Public Version Date: April 24, 2019
Public Version Number: 1
DI Record Publish Date: April 16, 2019