AccessGUDID - DEVICE: AESCULAP (04038653163953)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: FF482R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FF482R
Company Name: Aesculap AG

Primary DI Number: 04038653163953
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: Brain Spatula, 7 7/8", (200 mm), double ended, malleable, width: 7,500 mm, silicone, sterile, disposable, package of 10 pieces

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:	Yes
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?
35343	Brain spatula	A hand-held manual surgical instrument designed to manipulate neural tissue or to remove a material from a neural surface or vessel during brain surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a broad flat blunt blade (no sharp edges) that can be slightly curved or have various angles at the distal tip, or it can be double-ended. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAF	SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: b40c3643-d478-4a73-ba18-8d424552b02d
Public Version Date: May 14, 2020
Public Version Number: 1
DI Record Publish Date: May 06, 2020