Device
Headed Countersink, S 7.5mm
Manufacturer
Pace Surgical, Inc.
Model: PS2-1300075 Catalog: PS2-1300075 DI: 00810211043990 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-27 Current Version: 2026-05-05
Description
Headed Countersink, S 7.5mm
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: f66b1655-c70c-4a4d-9051-bfe654a50707
Distribution Status: In Commercial Distribution
DUNS Number: 119302878
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00810211043990
Type: Primary
Issuing Agency: GS1
GMDN
Code: 16462
Name: Surgical countersink, reusable
Definition:
A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.
FDA Product Codes
HWW
Countersink