FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Silicone Suction Cup (12 pk)
DI: B091230121
·
Model: 1
·
Gulden Ophthalmics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Silicone Suction Cup (12 pk)
- Primary DI
- B091230121
- Version / Model
- 1
- Company Name
- Gulden Ophthalmics Inc.
- Labeler DUNS
- 002373249
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2023-07-05
- Public Version
- 2
- Public Version Date
- 2024-09-05
- Public Version Status
- Update
- Public Device Record Key
- 8a736756-21bb-4a47-a4c8-fea5eb2eb9ec
- Distribution End Date
- 2024-09-04
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYE | Inserter/Remover Contact Lens | Ophthalmic | 886.5420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63962 | Corneal shield applicator | A hand-held manual device designed to place a shield on a patient’s cornea for protection during a medical procedure (e.g., periorbital surgery, dermatological laser treatment). It is typically in the form of a soft bulb or cup that when squeezed creates gentle suction against the shield, enabling the user to lift the shield and then gently position it on the patient’s cornea. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B091230121 | HIBCC | ||||
| Unit of Use | B091230120 | HIBCC |