FDA UDI
In Commercial Distribution
🇺🇸 United States
HEINE - LITHIUM ION BATTERY
DI: 00192896009516
·
Model: X-007.99.381
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HEINE - LITHIUM ION BATTERY
- Primary DI
- 00192896009516
- Version / Model
- X-007.99.381
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-24
- Public Version
- 2
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- f110df57-d350-4e97-bb29-ebb05d510f39
Device Description
HEINE LITHIUM ION BATTERY
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | 886.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46790 | Indirect binocular ophthalmoscope | An electrically-powered, head-worn, ophthalmic instrument designed to be held arm’s length from the patient to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, vitreous] using the examiner’s two eyes simultaneously (stereoscopic vision). It is intended to provide a wide field of view and produce an inverted (reversed) image of approximately 2 to 5 times magnification. It typically consists of a main light to illuminate the interior of the eyeball, lenses, filters and an illuminator beam to eliminate reflexes; it can be mounted on a headband or spectacle frames. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B099X007993810 | HIBCC | ||||
| Primary | 00192896009516 | GS1 |
Customer Contacts
- Phone
- 8008217496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142486 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5 | Inch |