AccessGUDID - DEVICE: Double Ended Orbital Globe Retractor-Elevator, 10mm / 14mm (08175700104524)

GUDID

Device Identifier (DI) Information

Brand Name: Double Ended Orbital Globe Retractor-Elevator, 10mm / 14mm
Version or Model: AS1-252
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS1-252
Company Name: AURORA SURGICAL, LLC

Primary DI Number: 08175700104524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968368832 *Terms of Use

Device Description: Double Ended Orbital Globe Retractor-Elevator, 10mm / 14mm

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?
35314	Periocular/lacrimal retractor, hand-held, reusable	A hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNI	Retractor, 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: 9b0e427b-390e-4133-9061-075e7da7a90c
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 11, 2022