AccessGUDID - DEVICE: CHATTANOOGA (00190446658771)

GUDID

Device Identifier (DI) Information

Brand Name: CHATTANOOGA
Version or Model: 8205
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DJO, LLC

Primary DI Number: 00190446658771
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081840873 *Terms of Use

Device Description: TRACTION KIT, IMPERIAL BLUE STOOL

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):	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?
42577	Physical therapy table, line-powered	A mains electricity (AC-powered) device designed for use in physical therapies for mobilization and rehabilitation of neurologically impaired and bedridden patients. It has powered adjustable table functions for height, position and vertical tilting from supine to upright, and typically incorporates foot supports, straps and exercisers (e.g., pulleys or rotators, arm slings, and leg exercisers). It is used during therapeutic exercises and massage typically to enhance blood circulation to the lower limbs in patients with neurological disorders (e.g., spinal cord injury, traumatic brain injury, stroke) and also to aid in muscle training and sense of balance.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INQ	TABLE, POWERED

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
Device Size Text, specify: N/A

Device Record Status

Public Device Record Key: 45c311d2-721a-40ca-8178-2ccaee6f3841
Public Version Date: November 09, 2020
Public Version Number: 1
DI Record Publish Date: October 30, 2020

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: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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