AccessGUDID - DEVICE: Perfo OSSEOSTAP Ø0.35 mm St (17630055505955)

GUDID

Device Identifier (DI) Information

Brand Name: Perfo OSSEOSTAP Ø0.35 mm St
Version or Model: 1501240
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1501240-001
Company Name: Bien-Air Surgery SA

Primary DI Number: 17630055505955
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481597719 *Terms of Use

Device Description: No description.

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?
11339	Middle ear drill bit	A cylindrical shaft of metal with a small cutting head (e.g., twisted or helicoidal) which when rotated will bore into the tissues of the middle ear to excavate, perforate, or excise tissue (e.g., ossicles, cartilage) during a middle ear (endaural) surgical procedure. This device is typically mounted into a powered surgical drill system handpiece that provides rotation. It is available in various cutting head sizes/shapes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EQJ	Bur, Ear, Nose And Throat
NLY	Microdebrider, Ent, High Speed, Single Use, Reprocessed
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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: Yes
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: e639d854-31c0-4825-9adc-f229231d8302
Public Version Date: February 28, 2023
Public Version Number: 5
DI Record Publish Date: May 27, 2020