AccessGUDID - DEVICE: Steerable Knee Walker with Basket (00616784021614)

GUDID

Device Identifier (DI) Information

Brand Name: Steerable Knee Walker with Basket
Version or Model: 10216
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784021614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *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:	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?
46437	Patient/medical device walker, clinical	An all-wheeled mobility aid in the form of a high support structure designed to provide unassisted post-surgery mobilization of an adult patient while he/she is connected to essential medical devices, e.g., intravenous (IV) drip(s), infusion and/or syringe pump(s), oxygen (O2) therapy device(s) and is pushed by the patient with handgrips. It is typically made of tubular metal (stainless steel or plastic coated) and typically includes integral IV poles/hangers, height-adjustable handgrips, interchangeable elbow supports, and an O2 cylinder holder. A power board with electrical outlets and cable (cord) for connection to the mains electricity supply, when necessary, may also be included.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITJ	Walker, Mechanical

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: 35279f16-7a98-465a-93cd-b9c2c61b9777
Public Version Date: October 09, 2024
Public Version Number: 3
DI Record Publish Date: October 08, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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