Model: CD-FN-4057
Catalog: CD-FN-4057
DI: 00840124525658
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Solid Tap 5.7mm
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a4dd4936-aaf4-4beb-b8c8-59ad14c9e2a2
Distribution Status:
In Commercial Distribution
DUNS Number:
080307067
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840124525658
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 56708
Name: Bone tap, single-use
Definition:
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 single-use device.
FDA Product Codes
HWX
Tap, Bone
Premarket Submissions
Submission Number:
K252961
Supplement Number:
000