AccessGUDID - DEVICE: I.CO.S® (10381780051848)

GUDID

Device Identifier (DI) Information

Brand Name: I.CO.S®
Version or Model: 119555ND
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NEWDEAL

Primary DI Number: 10381780051848
Issuing Agency: GS1
Commercial Distribution End Date: April 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The cannulated internal tap is used to prepare the thread of the 6.5mm compression screws. It is introduced through the protecting sleeve and screwed into the countersink area intended for the screw head and then gently unscrewed.

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?
17507	Bone tap, reusable	A surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWX	TAP, BONE

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: 2.7mm inner/10mm outer diameter X 208mm length

Device Record Status

Public Device Record Key: 26b3a6d5-94ab-42e8-8460-76b18d35bfc0
Public Version Date: April 28, 2025
Public Version Number: 5
DI Record Publish Date: May 26, 2017