AccessGUDID - DEVICE: MEDLINE (10197344033461)

GUDID

Device Identifier (DI) Information

Brand Name: MEDLINE
Version or Model: WCAA0123
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WCAA0123
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10197344033461
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: SPREADER BAR F/20" KR

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":	Yes
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?
64619	Wheelchair back rest positioner	A bracket-like device intended to be attached to the back canes of a wheelchair to accept the wheelchair back rest (not included) and allow for the adjustment of the back rest position (e.g., angle, depth, height). It is typically in the form of a clamp with hooks of adjustable position/orientation; pins intended to secure positioning may also be included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNN	COMPONENTS, WHEELCHAIR

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: 8cb7a9a3-e0c3-47e5-ab77-212deb8efef1
Public Version Date: November 25, 2024
Public Version Number: 1
DI Record Publish Date: November 15, 2024

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-5463
Email: service@medline.com

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