AccessGUDID - DEVICE: Top Shelf Orthopedics (00850016589033)

GUDID

Device Identifier (DI) Information

Brand Name: Top Shelf Orthopedics
Version or Model: 530015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 530015
Company Name: Top Shelf Manufacturing, LLC

Primary DI Number: 00850016589033
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 114134625 *Terms of Use

Device Description: Compact Sleeve, Sterile

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):	Yes
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?
62638	Upper-limb traction wrap/trap, single-use	A preformed device designed to encompass the fingers, hand or forearm to create a holder which can be attached to an external frame to provide traction/suspension of the upper limb during surgical procedures on the hand, arm or shoulder. It is typically made of synthetic polymer textile (e.g., nylon) and includes self-retaining fasteners (e.g., Velcro); it may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQZ	Component, Traction, Non-Invasive

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: 1f09e766-302e-4ece-b274-b713866c702c
Public Version Date: November 29, 2023
Public Version Number: 2
DI Record Publish Date: December 18, 2020