AccessGUDID - DEVICE: AESCULAP (04038653163724)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: FF389R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FF389R
Company Name: Aesculap AG

Primary DI Number: 04038653163724
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: MINOP Micro Forceps, working length: 10 1/2", (265 mm), diam. 2 mm, rotatable, toothed (1x2), consisting of FF432R, FF433R, FF439R,detachable, to be used with: FF399R

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?
35080	Rigid endoscopic tissue manipulation forceps, reusable	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWG	ENDOSCOPE, NEUROLOGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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) : 265.000 MM
Device Size Text, specify: Diameter (mm) : 2.000 MM

Device Record Status

Public Device Record Key: c2a00dee-c66c-4e58-9217-182c8a84e834
Public Version Date: November 29, 2021
Public Version Number: 9
DI Record Publish Date: May 19, 2016