AccessGUDID - DEVICE: Eardrum punch (04250676728562)

GUDID

Device Identifier (DI) Information

Brand Name: Eardrum punch
Version or Model: 15-761-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15-761-00
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250676728562
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: to roughen the tympanic membrane WL 9 cm

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":	Yes
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?
64337	Bone-coring punch, reusable	A hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL 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: 56941b23-4ff4-45e7-9b4d-3e7ff6e7aad1
Public Version Date: September 22, 2022
Public Version Number: 1
DI Record Publish Date: September 14, 2022