AccessGUDID - DEVICE: AESCULAP (04046964587283)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: MA444R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MA444R
Company Name: AESCULAP, INC.

Primary DI Number: 04046964587283
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 082594540 *Terms of Use

Device Description: BELLUCCI Micro scissors, straight, working length: 5 1/4", (135 mm), vertical cutting, (7 mm), ring handle, single action, 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?
33414	Ear scissors, reusable	A long, thin, hand-held manual surgical instrument designed to cut tissue during ear surgery; it is not intended for insertion through an endoscope. Sometimes referred to as alligator scissors, it typically has a slender body (to allow for restricted access) and small shearing blades which are hinged at the distal (working) end. It is made of metal and available in various sizes/lengths; the blades may have carbide inserts along the cutting edges. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZB	SCISSORS, EAR

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
Device Size Text, specify: Working length (mm) : 135.000 MM

Device Record Status

Public Device Record Key: 14f0a2b7-5bbe-4c0f-b89d-2716dbd07138
Public Version Date: May 04, 2020
Public Version Number: 1
DI Record Publish Date: April 24, 2020