FDA UDI
In Commercial Distribution
🇺🇸 United States
MR PHACO
DI: G412PH1855T0
·
Model: PH1855T
·
Crestpoint Management Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MR PHACO
- Primary DI
- G412PH1855T0
- Version / Model
- PH1855T
- Company Name
- Crestpoint Management Limited
- Labeler DUNS
- 836285668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-07
- Public Version
- 1
- Public Version Date
- 2025-06-16
- Public Version Status
- New
- Public Device Record Key
- ae8e1d78-5d00-4fe8-8560-aae126df5f1c
Device Description
Barraquer Iris Spatula .5mm Cylindrical Smooth tip, Angled/Vaulted 15mm from bend to tip, Round Knurled Handle, 122mm Overall Length, Titanium
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 |
|---|---|---|---|---|
| HND | Spatula, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 39610 | General-purpose surgical spatula | A hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G412PH1855T0 | HIBCC |