Needle Holders AS11-11017S

GUDID 08175700180047

ECO Barraquer Needle Holder, Standard Jaws 10mm, Straight With Lock, Stainless Steel

AURORA SURGICAL, LLC

Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer Ophthalmic suture/needle passer
Primary Device ID08175700180047
NIH Device Record Keyc723138b-f946-4f1e-a25e-dc7bc2e10bc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeedle Holders
Version Model NumberAS50-11017S
Catalog NumberAS11-11017S
Company DUNS968368832
Company NameAURORA SURGICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108175700180047 [Primary]

FDA Product Code

HNRForceps, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


[08175700180047]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-14
Device Publish Date2023-12-06

On-Brand Devices [Needle Holders]

08175700144018Needle Holder / Scissors, Curved (Used to cut suture only.)
08175700144001Needle Holder / Scissors, Straight (Used to cut suture only.)
08175700143516Kalt Needle Holder, Standard, Curved 12mm Jaws
08175700143509Kalt Needle Holder, Standard, Straight 12mm Jaws
08175700143042Castroviejo Needle Holder, Standard Jaws 10mm, Curved Without Lock, (For 4.0-7.0 Suture) Stainle
08175700143035Castroviejo Needle Holder, Standard Jaws 10mm, Curved Without Lock, (For 4.0-7.0 Suture)
08175700143028Castroviejo Needle Holder, Standard Jaws 10mm, Curved With Lock, (For 4.0-7.0 Suture)
08175700143011Castroviejo Needle Holder, Standard Jaws 10mm, Straight Without Lock, (For 4.0-7.0 Suture)
08175700143004Castroviejo Needle Holder, Standard Jaws 10mm, Straight With Lock, (For 4.0-7.0 Suture)
08175700142632Barraquer Needle Holder, Extra Delicate Jaws 6mm, Curved Without Lock, 115mm, Titanium
08175700142526Barraquer Needle Holder, Extra Delicate Jaws 6mm, Curved With Lock, 115mm, Titanium
08175700142519Barraquer Needle Holder, Extra Delicate Jaws 6mm, Straight Without Lock, 115mm, Titanium
08175700142502Barraquer Needle Holder, Extra Delicate Jaws 6mm, Straight With Lock, 115mm, Titanium
08175700142038Barraquer Needle Holder, Delicate Jaws 11mm, Curved Without Lock, 115mm, Titanium
08175700142021Barraquer Needle Holder, Delicate Jaws 11mm, Curved With Lock, 115mm, Titanium
08175700142014Barraquer Needle Holder, Delicate Jaws 11mm, Straight Without Lock, 115mm, Titanium
08175700142007Barraquer Needle Holder, Delicate Jaws 11mm, Straight With Lock, 115mm, Titanium
08175700141550Barraquer Needle Holder, Standard Jaws 10mm, Curved Without Lock, 115mm, Titanium
08175700141543Barraquer Needle Holder, Standard Jaws 10mm, Curved With Lock, 115mm, Titanium
08175700141536Barraquer Needle Holder, Standard Jaws 10mm, Straight Without Lock, 115mm, Titanium
08175700141529Barraquer Needle Holder, Standard Jaws 10mm, Straight With Lock, 115mm, Titanium
08175700141512Barraquer Needle Holder, Standard Jaws 9mm Curved Without Lock, 115mm, Titanium
08175700141505Barraquer Needle Holder, Standard Jaws 9mm, Curved With Lock, 115mm, Titanium
08175700141079Barraquer Needle Holder, Delicate Jaws 9mm, Curved Without Lock, 112mm, Titanium
08175700141062Barraquer Needle Holder, Delicate Jaws 9mm, Curved Without Lock, 112mm, Titanium
08175700141055Barraquer Needle Holder, Delicate Jaws 9mm, Straight Without Lock, 112mm, Titanium
08175700141048Barraquer Needle Holder, Delicate Jaws 9mm, Straight Without Lock, 112mm, Titanium
08175700141031Barraquer Needle Holder, Delicate Jaws 6mm, Curved Without Lock, 110mm, Titanium
08175700141024Barraquer Needle Holder, Delicate Jaws 6mm, Curved With Lock, 110mm, Titanium
08175700141017Barraquer Needle Holder, Delicate Jaws 6mm, Straight Without Lock, 110mm, Titanium
08175700141000Barraquer Needle Holder, Delicate Jaws 6mm, Straight With Lock, 110 mm, Titanium
08175700180078ECO Barraquer Needle Holder, Standard Jaws 10mm, Curved Without Lock, Stainless Steel
08175700180061ECO Barraquer Needle Holder, Standard Jaws 10mm, Curved With Lock, Stainless Steel
08175700180054ECO Barraquer Needle Holder, Standard Jaws 10mm, Straight Without Lock, Stainless Steel
08175700180047ECO Barraquer Needle Holder, Standard Jaws 10mm, Straight With Lock, Stainless Steel

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.