FDA UDI
In Commercial Distribution
🇺🇸 United States
Applanation Tonometer
DI: 06973211070671
·
Model: SK-R
·
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Applanation Tonometer
- Primary DI
- 06973211070671
- Version / Model
- SK-R
- Company Name
- CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
- Labeler DUNS
- 545824560
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-02
- Public Version
- 1
- Public Version Date
- 2020-07-10
- Public Version Status
- New
- Public Device Record Key
- 5d25bd96-426b-4022-954b-ea27716bea9a
Device Description
It is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid the diagnosis of glaucoma
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
- No
- 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 |
|---|---|---|---|---|
| HKY | Tonometer, Manual | Ophthalmic | 886.1930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32721 | Ophthalmic tonometer, manual | An ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26973211070491 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 06973211070671 | GS1 | ||||
| Package | 26973211070507 | GS1 | 4 | In Commercial Distribution | ||
| Package | 26973211070514 | GS1 | 6 | In Commercial Distribution | ||
| Package | 26973211070521 | GS1 | 8 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191314 | 000 |