AccessGUDID - DEVICE: AESCULAP (04046964589188)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: MA660R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MA660R
Company Name: AESCULAP, INC.

Primary DI Number: 04046964589188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 082594540 *Terms of Use

Device Description: SCHEER Wire Bending Forceps, 5 1/8", (130 mm), smooth, 7 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?
47510	ENT wire crimper	A hand-held manual surgical instrument designed to bend wire directly in the cavities of the ears, nose, or throat. It is typically a straight or curved forceps-like instrument with a terminal end appropriately configured to manipulate wires in the cavities of the ears, nose, or throat. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNN	CRIMPER, WIRE, ENT, NON-STERILE

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: 567ca3c5-60ae-46fd-98df-038222f6172d
Public Version Date: May 18, 2020
Public Version Number: 1
DI Record Publish Date: May 08, 2020