| Primary Device ID | G346EP120 |
| NIH Device Record Key | 89e0811b-9f33-4f6f-b262-309ffa54aa8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epsilon USA |
| Version Model Number | EP-12 |
| Company DUNS | 917922762 |
| Company Name | EPSILON EYE CARE PRIVATE LIMITED |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com | |
| Phone | (909)984-4614 |
| epsilonusa1@gmail.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G346EP120 [Primary] |
| HND | Spatula, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
[G346EP120]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-02 |
| Device Publish Date | 2023-05-25 |
| G346ESF260 | Alio Conjunctiva Forceps (85 mm overall) Titanium |
| G346ESF250 | Alio Swan Neck .12 1x2 Teeth W/ Tying Platform Forceps (83 mm overall) Titanium |
| G346ESF240 | Swan Neck W/ Notch Forceps (83 mm overall) Titanium |
| G346ESF230 | Alio Curved W/ Tying Platform Forceps (85 mm overall) Titanium |
| G346ESF220 | Polack Double Corneal Fixation Forceps (86 mm overall) Titanium |
| G346ESF21B0 | Sub Capsularhexis 2.2 mm Forceps Blunt (104 mm overall) Titanium |
| G346ESF210 | Sub Capsularhexis 2.2 mm Forceps (104 mm overall) Titanium |
| G346ESF200 | Capsulorhexis Forceps Sharp Cystotome Tips Curved Shanks (85 mm overall) Titanium |
| G346ESF190 | Kelman McPherson Angled Forceps .12 1x2 Teeth (85 mm overall) Titanium |
| G346ESF180 | Moorfield Serrated Forceps (85 mm overall) Titanium |
| G346ESF170 | Lims 0.12 1x2 Teeth Forceps With Tying Platform (85 mm overall) Titanium |
| G346ESF160 | Capsulorhexis Forceps with Sharp Tips Titanium (85 mm overall) |
| G346ESF150 | Colibri 0.20 1x2 Teeth Forceps with Tying Platform Titanium (Overall 85mm) |
| G346ESF140 | Colibri .12 1x2 Teeth Forceps with Tying Platform Titanium (Overall 85mm) Colibri .30 1x2 Teet |
| G346ESF130 | Pierse Colibri Corneal Forceps with Tying Platform (Overall 85mm) Titanium |
| G346ESF120 | Colibri Tying Straight Forceps (Overall 85mm) Titanium |
| G346ESF110 | Kellman McPherson Angled Forceps W/ 11mm Tips (Overall 85mm) Titanium |
| G346ESF100 | Kelman McPherson Angled Forceps W/ 10mm Tips Titanium Kelman McPherson Angled Forceps W/ 5mm Tip |
| G346ESF090 | 0.20 1 X 2 Fine Teeth Curved Forceps With Tying Platform Titanium (Overall 85mm) |
| G346ESF080 | 0.12 1x2 Fine Teeth Curved Forceps With Tying Platform Titanium (Overall 85mm) |
| G346ESF070 | Notched Curved Forceps Titanium |
| G346ESF060 | Standard Handle Tying Forceps Curved (Overall 85 mm) Titanium |
| G346ESF050 | 0.20 1x2 Teeth with Tying Platform Standard Handle (85 mm) Titanium |
| G346ESF04B0 | 0.12B 1x2 Bonn Teeth with Tying Platform Standard Handle (85 mm) Titanium 0.30B 1x2 Bonn Teeth |
| G346ESF040 | 0.12 1x2 Teeth with Tying Platform Standard Handle (85 mm) Titanium 0.30 1x2 Teeth with Tying Pl |
| G346ESF030 | Notched Straight Forceps with Tying Platform (Overall 85mm) Titanium |
| G346ESF020 | Tying Forceps Straight (Overall 85mm) Titanium |
| G346ESF010 | Plain Straight Forceps (Overall 85mm) Titanium |
| G346ESF420 | Bishop Harmon Dressing Forceps (85 mm overall) Titanium |
| G346ESF410 | Lens Loading Forceps Angle (85 mm overall) Titanium |
| G346ESF400 | Lens Loading Forceps Straight (85 mm overall) Titanium |
| G346ESF390 | Straight Tooth 0.10 mm 1x2 Teeth Forceps (85 mm overall) Titanium |
| G346ESF380 | Intacs Forceps (85 mm overall) Titanium |
| G346ESF370 | Pineda Lens Folding Forceps (85 mm overall) Titanium |
| G346ESF360 | Bishop-Harmon Tissue Forceps Straight 0.30 mm 1x2 Teeth (85 mm overall) Titanium Bishop-Harmon T |
| G346ESF350 | Basak Iridectomy Forceps (85 mm overall) Titanium |
| G346ESF340 | Capsulorhexis Forceps Micro 2.2 (85 mm overall) Titanium |
| G346ESF330 | Micro Colibri 0.12 1x2 Teeth Forceps with Tying Platform (60.5 mm overall) Titanium |
| G346ESF320 | Moorfield Angled Forceps Serrated Forceps (85 mm overall) Titanium |
| G346ESF31C0 | Minitoya Capsulorhexis with Sharp Tips With Masket Curve(85 mm overall) Titanium |
| G346ESF310 | Minitoya Capsulorhexis with Sharp Tips Short Forceps (85 mm overall) Titanium |
| G346ESF300 | Vejarano Angled .40 1x2 Teeth Forceps With Tying Platform (85 mm overall) Titanium |
| G346ESF29C0 | Utrata Forceps Curved With Platform (85 mm overall) Titanium |
| G346ESF290 | Utrata Forceps Angled With Platform (85 mm overall) Titanium |
| G346ESF280 | Alio Curved Tying Forceps W/ Cross Serration (85 mm overall) Titanium |
| G346ESF270 | Alio McPherson Angled Tying Forceps (85 mm overall) Titanium |
| G346EMF14P0 | Micro Handle Colibri 0.12mm 1x2 Teeth Forceps With Tying Platform (75 mm overall) Titanium |
| G346EMF140 | Micro Handle Colibri 0.12mm 1x2 Teeth Forceps (75 mm overall) Titanium |
| G346ECF04B0 | .12 1x2 Bonn Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Titanium .20 |
| G346ECF040 | .12 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Titanium .20 1x2 |