FDA UDI
In Commercial Distribution
🇺🇸 United States
MR PHACO
DI: G412PH31270
·
Model: PH3127
·
Crestpoint Management Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MR PHACO
- Primary DI
- G412PH31270
- Version / Model
- PH3127
- Company Name
- Crestpoint Management Limited
- Labeler DUNS
- 836285668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-03
- Public Version
- 1
- Public Version Date
- 2025-06-11
- Public Version Status
- New
- Public Device Record Key
- 2b3f7b09-b297-460c-9dcf-f2ad033dc8ba
Device Description
Anis Needle Holder Extra Delicate Curved 9mm Smooth Jaws, With Lock, Round Knurled Handle, 127mm 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 |
|---|---|---|---|---|
| HNM | Needle, Ophthalmic Suturing | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63492 | Ophthalmic suture/needle passer | A hand-held manual ophthalmic surgical instrument designed for passing (driving) a suture needle with a pre-attached suture through ocular structures (e.g., ciliary sulcus) during an ophthalmic surgical procedure (e.g., securing the haptics of an intraocular lens during implantation). It is a syringe-like device with a distal tip and a manual needle-driving mechanism. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G412PH31270 | HIBCC |