AccessGUDID - DEVICE: AESCULAP (04046963848071)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: PL818R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL818R
Company Name: Aesculap AG

Primary DI Number: 04046963848071
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: Clip Removing Forceps, single-fire, 12 1/4", (310 mm), diam. 12 mm, Size L, orange, reusable, to be used with: PL468SU, PL471SU

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?
16787	Skin staple remover, reusable	A hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is made of metallic or synthetic polymer materials with blades at the distal end designed for grasping, opening, and removing surgical staples. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDO	Applier, surgical, clip

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: Diameter (mm) : 12.000 MM
Device Size Text, specify: Working length (mm) : 310.000 MM

Device Record Status

Public Device Record Key: ce290abf-313d-4dcd-9a5d-019b255679eb
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: April 24, 2020