FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10193489109627
·
Model: MDSR006567
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10193489109627
- Version / Model
- MDSR006567
- Catalog Number
- MDSR006567
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-17
- Public Version
- 1
- Public Version Date
- 2022-02-25
- Public Version Status
- New
- Public Device Record Key
- 615830b7-cb50-4874-bdd4-97dca5be0d28
Device Description
GONIOMETER, ROUND HEAD, 12''
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KQW | Goniometer, nonpowered | Orthopedic | 888.1520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33651 | Manual goniometer | A non-powered, manually-operated measuring device, graduated in degrees (e.g., from 0 to 360 degrees), designed to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. It is typically used by rheumatologists, physiotherapists, orthopaedists and general practitioners to evaluate joint movement (e.g., ankle, finger, knee, shoulder or spine) before and after a medical/surgical intervention. It may be made of plastic or stainless steel and is available in various designs (e.g., protractor-like with pivoting arms, dial-like with twin rotating dials). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10193489109627 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]