FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Schioetz Tonometer - Allen Wrench Modification
DI: B091131100
·
Model: 13110
·
Gulden Ophthalmics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Schioetz Tonometer - Allen Wrench Modification
- Primary DI
- B091131100
- Version / Model
- 13110
- Catalog Number
- 13110
- Company Name
- Gulden Ophthalmics Inc.
- Labeler DUNS
- 002373249
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- b686c1c6-4d60-4f46-a285-058627c3b629
- Distribution End Date
- 2023-06-29
Device Description
Manual tonometer used to gauge internal pressure within the eye. An allen wrench can be used to adjust weight settings.
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | B091131100 | HIBCC |
Customer Contacts
- Phone
- 1-800-659-2250
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 2 | Inch | |
| Length | 5.25 | Inch |