FDA UDI
In Commercial Distribution
🇺🇸 United States
Diamatrix
DI: 00813059016232
·
Model: H560-.8-L-S
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Diamatrix
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diamatrix
- Primary DI
- 00813059016232
- Version / Model
- H560-.8-L-S
- Catalog Number
- H560-.8-L-S
- Company Name
- Diamatrix
- Labeler DUNS
- 809555139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-21
- Public Version
- 1
- Public Version Date
- 2020-07-29
- Public Version Status
- New
- Public Device Record Key
- c09ce5fb-59ea-415f-aab6-6fce5716598e
Device Description
Chang Microfinger & Quick Chop, Unique double sided instrument, Modified Microfinger, Unique C-Shaped Chopper with blunt tip ~ Quick Chop, .8mm Pointed Sharp tip, Both Angled 10mm from bend to tip, Intended to be used in the left hand, Round knurled Handle, 134mm total length, Stainless Steel
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HNQ | Hook, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32754 | Ocular hook/spatula/manipulator, reusable | A hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813059016232 | GS1 |