AccessGUDID - DEVICE: AESCULAP (04038653147793)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: DC081R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DC081R
Company Name: Aesculap AG

Primary DI Number: 04038653147793
Issuing Agency: GS1
Commercial Distribution End Date: April 23, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: BLACK Enamel Chisel, angled, 6" (150 mm), right, hatchet-shaped, hexagonal handle, 20 9 6

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?
35811	Dental excavator, reusable	A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMM	CHISEL, OSTEOTOME, SURGICAL

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: a975c52e-eeee-475f-a4eb-9c511c892fc3
Public Version Date: May 28, 2021
Public Version Number: 2
DI Record Publish Date: June 17, 2020