| Primary Device ID | 08175700141550 |
| NIH Device Record Key | 05360686-192d-45ab-93ee-5ca49b28600c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Needle Holders |
| Version Model Number | AS11-020T |
| Catalog Number | AS11-020T |
| Company DUNS | 968368832 |
| Company Name | AURORA SURGICAL, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08175700141550 [Primary] |
| HNR | Forceps, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
[08175700141550]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-18 |
| Device Publish Date | 2023-07-10 |
| 08175700144018 | Needle Holder / Scissors, Curved (Used to cut suture only.) |
| 08175700144001 | Needle Holder / Scissors, Straight (Used to cut suture only.) |
| 08175700143516 | Kalt Needle Holder, Standard, Curved 12mm Jaws |
| 08175700143509 | Kalt Needle Holder, Standard, Straight 12mm Jaws |
| 08175700143042 | Castroviejo Needle Holder, Standard Jaws 10mm, Curved Without Lock, (For 4.0-7.0 Suture) Stainle |
| 08175700143035 | Castroviejo Needle Holder, Standard Jaws 10mm, Curved Without Lock, (For 4.0-7.0 Suture) |
| 08175700143028 | Castroviejo Needle Holder, Standard Jaws 10mm, Curved With Lock, (For 4.0-7.0 Suture) |
| 08175700143011 | Castroviejo Needle Holder, Standard Jaws 10mm, Straight Without Lock, (For 4.0-7.0 Suture) |
| 08175700143004 | Castroviejo Needle Holder, Standard Jaws 10mm, Straight With Lock, (For 4.0-7.0 Suture) |
| 08175700142632 | Barraquer Needle Holder, Extra Delicate Jaws 6mm, Curved Without Lock, 115mm, Titanium |
| 08175700142526 | Barraquer Needle Holder, Extra Delicate Jaws 6mm, Curved With Lock, 115mm, Titanium |
| 08175700142519 | Barraquer Needle Holder, Extra Delicate Jaws 6mm, Straight Without Lock, 115mm, Titanium |
| 08175700142502 | Barraquer Needle Holder, Extra Delicate Jaws 6mm, Straight With Lock, 115mm, Titanium |
| 08175700142038 | Barraquer Needle Holder, Delicate Jaws 11mm, Curved Without Lock, 115mm, Titanium |
| 08175700142021 | Barraquer Needle Holder, Delicate Jaws 11mm, Curved With Lock, 115mm, Titanium |
| 08175700142014 | Barraquer Needle Holder, Delicate Jaws 11mm, Straight Without Lock, 115mm, Titanium |
| 08175700142007 | Barraquer Needle Holder, Delicate Jaws 11mm, Straight With Lock, 115mm, Titanium |
| 08175700141550 | Barraquer Needle Holder, Standard Jaws 10mm, Curved Without Lock, 115mm, Titanium |
| 08175700141543 | Barraquer Needle Holder, Standard Jaws 10mm, Curved With Lock, 115mm, Titanium |
| 08175700141536 | Barraquer Needle Holder, Standard Jaws 10mm, Straight Without Lock, 115mm, Titanium |
| 08175700141529 | Barraquer Needle Holder, Standard Jaws 10mm, Straight With Lock, 115mm, Titanium |
| 08175700141512 | Barraquer Needle Holder, Standard Jaws 9mm Curved Without Lock, 115mm, Titanium |
| 08175700141505 | Barraquer Needle Holder, Standard Jaws 9mm, Curved With Lock, 115mm, Titanium |
| 08175700141079 | Barraquer Needle Holder, Delicate Jaws 9mm, Curved Without Lock, 112mm, Titanium |
| 08175700141062 | Barraquer Needle Holder, Delicate Jaws 9mm, Curved Without Lock, 112mm, Titanium |
| 08175700141055 | Barraquer Needle Holder, Delicate Jaws 9mm, Straight Without Lock, 112mm, Titanium |
| 08175700141048 | Barraquer Needle Holder, Delicate Jaws 9mm, Straight Without Lock, 112mm, Titanium |
| 08175700141031 | Barraquer Needle Holder, Delicate Jaws 6mm, Curved Without Lock, 110mm, Titanium |
| 08175700141024 | Barraquer Needle Holder, Delicate Jaws 6mm, Curved With Lock, 110mm, Titanium |
| 08175700141017 | Barraquer Needle Holder, Delicate Jaws 6mm, Straight Without Lock, 110mm, Titanium |
| 08175700141000 | Barraquer Needle Holder, Delicate Jaws 6mm, Straight With Lock, 110 mm, Titanium |
| 08175700180078 | ECO Barraquer Needle Holder, Standard Jaws 10mm, Curved Without Lock, Stainless Steel |
| 08175700180061 | ECO Barraquer Needle Holder, Standard Jaws 10mm, Curved With Lock, Stainless Steel |
| 08175700180054 | ECO Barraquer Needle Holder, Standard Jaws 10mm, Straight Without Lock, Stainless Steel |
| 08175700180047 | ECO Barraquer Needle Holder, Standard Jaws 10mm, Straight With Lock, Stainless Steel |