FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Adlite™
DI: 00634782013288
·
Model: 351PZ
·
AMERICAN DIAGNOSTIC CORP
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
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Basic Information
- Brand Name
- Adlite™
- Primary DI
- 00634782013288
- Version / Model
- 351PZ
- Catalog Number
- 351PZ
- Company Name
- AMERICAN DIAGNOSTIC CORP
- Labeler DUNS
- 108999095
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-11-04
- Public Version
- 3
- Public Version Date
- 2019-04-22
- Public Version Status
- Update
- Public Device Record Key
- c46e0a3d-ca7d-4a9d-b552-702cd6643469
- Distribution End Date
- 2019-04-19
Device Description
Disposable Penlight, 6/pkg,White w/Pupil Gauge, Generic
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| KYT | Light, Examination, Medical, Battery Powered | General Hospital | 880.6350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38832 | Hand-held examination/treatment light | A small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00634782513221 | GS1 | Master Case | 10 | Not in Commercial Distribution | 2019-04-19 |
| Package | 00634782813222 | GS1 | Inner Pack | 6 | Not in Commercial Distribution | 2019-04-19 |
| Primary | 00634782013288 | GS1 | ||||
| Unit of Use | 00634782024529 | GS1 |
Customer Contacts
- Phone
- 1-800-232-2670
- [email protected]