AccessGUDID - DEVICE: HUMAC NORM (00860139000308)

GUDID

Device Identifier (DI) Information

Brand Name: HUMAC NORM
Version or Model: 502140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 502140-00
Company Name: COMPUTER SPORTS MEDICINE INC.

Primary DI Number: 00860139000308
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 059291894 *Terms of Use

Device Description: HUMAC NORM Extremity System; Dynamometer

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?
34395	Back/leg/chest dynamometer	An analogue instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess a variety of movements (e.g., leg abduction, lifting) and is typically used to test and control a patient's muscle strength as part of a rehabilitation program.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IKK	System, Isokinetic Testing And Evaluation

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
Special Storage Condition, Specify: Relative Humidity for Handling and Storage is noncondensing
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c2368161-b088-4a11-bf15-f481d1de79d2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 14, 2016

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 781-297-2034
Email: dev@csmisolutions.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES