AccessGUDID - DEVICE: AESCULAP (04046964586736)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: MA378R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MA378R
Company Name: AESCULAP, INC.

Primary DI Number: 04046964586736
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 082594540 *Terms of Use

Device Description: WRIGHT Micro Ear Needle, curved, 5 1/8", (130 mm), tip length: 2 mm, non-sterile, reusable

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):	Yes
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?
62701	Ophthalmic needle, reusable	A slender, straight hollow instrument, with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles; it may also be intended for diagnostic aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDM	NEEDLE, ASPIRATION AND INJECTION, REUSABLE

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: aa6f8311-8d67-4278-8716-bcc53a6e32e0
Public Version Date: September 29, 2022
Public Version Number: 2
DI Record Publish Date: May 08, 2020