AccessGUDID - DEVICE: Needle Holders (08175700141017)

GUDID

Device Identifier (DI) Information

Brand Name: Needle Holders
Version or Model: AS11-002T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS11-002T
Company Name: AURORA SURGICAL, LLC

Primary DI Number: 08175700141017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968368832 *Terms of Use

Device Description: Barraquer Needle Holder, Delicate Jaws 6mm, Straight Without Lock, 110mm, Titanium

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63492	Ophthalmic suture/needle passer	A hand-held manual ophthalmic surgical instrument designed for passing (driving) a suture needle with a pre-attached suture through ocular structures (e.g., ciliary sulcus) during an ophthalmic surgical procedure (e.g., securing the haptics of an intraocular lens during implantation). It is a syringe-like device with a distal tip and a manual needle-driving mechanism. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNR	Forceps, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 039e5bf0-fedd-4777-add6-ad2a6e8c7c64
Public Version Date: July 18, 2023
Public Version Number: 1
DI Record Publish Date: July 10, 2023