FDA UDI
In Commercial Distribution
🇺🇸 United States
MR PHACO
DI: G412DP20600
·
Model: DP2060
·
Crestpoint Management Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MR PHACO
- Primary DI
- G412DP20600
- Version / Model
- DP2060
- Company Name
- Crestpoint Management Limited
- Labeler DUNS
- 836285668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-27
- Public Version
- 1
- Public Version Date
- 2025-06-04
- Public Version Status
- New
- Public Device Record Key
- 20d52a4c-c997-484a-9065-381b781c2337
Device Description
Schocket Scleral Depressor DBL-Ended T-Shaped Hammer Head tip, / Half Ball-Shaped tip, Both Sides are Slightly Angled 16mm from bend to tip, Comes with Pocket clip, Flat Handle, 137mm Overall Length, Stainless Steel
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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HNX | Depressor, Orbital | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16465 | Orbital depressor, reusable | A hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination. Sometimes referred to as a scleral depressor, it is often a double-ended device of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working end(s) slightly angled to improve organ/tissue manipulation. It is usually made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G412DP20600 | HIBCC |