| Primary Device ID | G2231194120 |
| NIH Device Record Key | 9cca1d2e-f53c-4200-9a9c-bfb6a931ee8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medetz Surgical Instruments |
| Version Model Number | 11-9412 |
| Company DUNS | 876570990 |
| Company Name | Medetz Surgical Instruments LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 |
| emichaels@medetzsurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G2231194120 [Primary] |
| HNZ | Curette, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
[G2231194120]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-29 |
| Device Publish Date | 2023-11-21 |
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| G22312049090 | Barraquer Speculum Round Blades .035" Stainless wire, 14mm Closed Round Blades, 18mm Blade Sprea |
| G223113095S0 | Barraquer solid-blade lid speculum - adult size, 1 5/8", 14mm blades, 18mm blade spread |
| G2231130950 | Barraquer wire lid speculum - adult size, 1 1/2", closed 14mm blades, 18mm blade spread |
| G2231550830 | Inner-Facelift Zygomatic Arch Elevator |
| G22314943944S0 | Connor Style Wand .5mm ball tip, Straight shaft, Round handle, Titanium |
| G22314943944A0 | Connor Style Wand .5mm ball tip, Angled 10mm from bend to tip, Round handle, Titanium |
| G22314796003A0 | Connor Style Wand .5mm ball tip, Angled 10mm from bend to tip, Round handle, Stainless Steel |
| G223147960030 | Connor Style Wand .5mm ball tip, Straight shaft, Round handle, Stainless Steel |
| G2231340210 | Operating Scissors 5 1/2" |
| G2231317200 | Iris Scissors 4 1/2" curved |
| G22313100 | 3K 10CM ROUND KNURLED Handle |
| G22312640690 | McIntyre anterior chamber cannula, 30 gauge, 12mm angled 45 degree tip |
| G22312241290 | Sinskey II lens manipulating hook, angled, 0.2mm diameter blunt tip, flat handle |
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| G22312045640 | Lieberman open wire lid speculum, angled 45 degree, v-wire adjustable open blades, thumb-screw t |
| G22312045600 | Lieberman open wire lid speculum, angled 45°, k-wire adjustable 15mm open blades, thumb-screw t |
| G22311424510 | Stevens tenotomy scissors, curved blades with blunt tips, ring handle |
| G2231113100 | Mendez degree gauge |
| G22312643530 | Chang Nucleus Hydro dissector cannula 27 gauge 1.5mm flat standard tip angled 90 degree with bev |
| G22312449290 | Kelman-McPherson tying forceps, angled 7.5mm smooth jaws, flat 3-hole handle |
| G22312449090 | McPherson tying forceps, 3 7/8", angled smooth jaws, flat 3-hole handle |
| G22312244110 | Kuglen iris hook & lens manipulator, 4 1/2", push-pull model, straight, round handle |
| G22312241220 | Sinskey II lens manipulating hook, angled, 0.2mm diameter blunt tip, round handle |
| G22312240790 | Sinskey Lens Manipulating Hook .25mm Diameter Blunt tip, Straight Shaft, Flat Handle, 120mm Over |
| G22312215800 | Lester IOL Manipulator .25mm Diameter tip, Angled/Vaulted, Round handle, Stainless Steel |
| G22312213070 | Drysdale Nucleus Manipulator Paddle Shaped Tip, Round handle, Stainless Steel |
| G22312212180 | Nagahara Phaco Chopper Centered Flat Interior Cutting Edge, Angled 10mm from bend to tip, Round |
| G223120132T0 | Thornton Fixation Ring: Swivel 13mm C Style with 15 Degree Markings, Round Handle, TITANIUM wit |
| G2231127370 | Castroviejo needle holder, 5 3/8", gently curved medium jaws flat handle with lock |
| G2231122110 | Westcott utility stitch scissors, 5 1/8", blades with rounded sharp tips, flat handle |
| G2231121940 | Castro-Colibri Forceps |
| G2231118920 | Nugent utility forceps, 4 1/4", angled 45 degree jaws, 10mm long serrated tips, narrow handle |
| G2231118110 | Bonn suturing forceps, 3 3/4", straight shafts, 0.12mm 1x2 teeth, with tying platform |
| G2231108930 | Bonaccolto utility forceps, 4 3/8", straight shafts , serrated tips, narrow handle |
| G223110777C0 | Harms-Tubingen tying forceps, 4", curved shafts with 7mm tying platforms, narrow handle |