AccessGUDID - DEVICE: MTI (10840118400135)

GUDID

Device Identifier (DI) Information

Brand Name: MTI
Version or Model: 4000075
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4000075
Company Name: Medical Technology Industries, Inc.

Primary DI Number: 10840118400135
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053947946 *Terms of Use

Device Description: 421M Exam Chair

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?
38458	Examination/treatment table, manual	A non-mobile table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may facilitate a paper roll holder from which paper is pulled to cover the table surface as a hygienic barrier for each new patient. This device is typically used in examination rooms or doctors' surgeries as a statically placed table.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRK	Chair, Examination And Treatment

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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d62ddc72-87a1-42e7-ad12-b3f5a1644904
Public Version Date: February 11, 2020
Public Version Number: 1
DI Record Publish Date: February 03, 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 801-887-5114
Email: customer.service@mti.net

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