FDA UDI
In Commercial Distribution
🇺🇸 United States
HUMAC Cybex NORM (R)
DI: 00860139000322
·
Model: 504192
·
COMPUTER SPORTS MEDICINE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HUMAC Cybex NORM (R)
- Primary DI
- 00860139000322
- Version / Model
- 504192
- Catalog Number
- 504192
- Company Name
- COMPUTER SPORTS MEDICINE INC.
- Labeler DUNS
- 059291894
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2d73b12c-b051-439d-abd8-a5a8eb7eedd8
Device Description
HUMAC Cybex NORM Extremity System; Dynamometer – Refurbished
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | Physical Medicine | 890.1925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860139000322 | GS1 |
Customer Contacts
- Phone
- 781-297-2034
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Relative Humidity for Storage and Handling is noncondensing
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius