FDA UDI
In Commercial Distribution
🇺🇸 United States
ADC®
DI: 00634782072889
·
Model: 3698BK
·
AMERICAN DIAGNOSTIC CORP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ADC®
- Primary DI
- 00634782072889
- Version / Model
- 3698BK
- Catalog Number
- 3698BK
- Company Name
- AMERICAN DIAGNOSTIC CORP
- Labeler DUNS
- 108999095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 10e961c4-6f49-458b-b683-9b0c322fcacb
Device Description
Babinski Hammer, Adjustable,
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GWZ | Percussor | Neurology | 882.1700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11950 | Percussion hammer, manual, reusable | A hand-held manual instrument designed to be used by an examining physician to gently tap near a patient's joints to test reflexes (e.g., patellar, ankle reflexes). It consists of a handle and shaft typically made of stainless steel, and has a head that may be ring, wedge, or dome shaped and is made of a soft material (e.g., rubber or plastic). Some devices may be fitted with a spike, brush, or other detachable component at the proximal end that can be used for neurological examinations. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00634782572501 | GS1 | Master Case | 5 | In Commercial Distribution | |
| Package | 00634782872502 | GS1 | Inner pack | 10 | In Commercial Distribution | |
| Primary | 00634782072889 | GS1 |
Customer Contacts
- Phone
- 1-800-232-2670
- [email protected]