FDA UDI
In Commercial Distribution
🇺🇸 United States
Stephens Instruments
DI: 00810799033413
·
Model: S5-1058
·
KRISHNA IMPORTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stephens Instruments
- Primary DI
- 00810799033413
- Version / Model
- S5-1058
- Catalog Number
- S5-1058
- Company Name
- KRISHNA IMPORTS INC
- Labeler DUNS
- 081853285
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-22
- Public Version
- 1
- Public Version Date
- 2020-09-30
- Public Version Status
- New
- Public Device Record Key
- 6ad4c86b-1eba-452f-adaa-e7738391df1f
Device Description
Stephens Meibomian Gland Expressor
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
- Yes
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNS | Expressor | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62775 | Meibomian gland manual expressor/evaluator | A non-powered, hand-held manual ophthalmic instrument intended to be used to apply pressure to the lower eyelid to facilitate natural release and/or expression of meibomian gland secretions (meibum) for diagnostic evaluation during a routine eye examination and/or to treat dry eye syndrome. It is a small tool with a handle and a distal end of various configurations (e.g., shaft, paddle, roller, tweezers-like) designed to be gently pressed against the outer skin of the lower eyelid or to gently squeeze the lower eyelid. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810799033413 | GS1 |
Customer Contacts
- Phone
- +1(859)259-4925
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature