I.co.s®

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: I.CO.S® FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: The long cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is used to drill the bone for the insertion of the 4.0mm. FDA UDI
Model / Reference: 119516ND FDA UDI
Description: The long cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is used to drill the bone for the insertion of the 4.0mm. FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780045298 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Cannulated surgical drill bit, single-use

I.co.s® by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cannulated surgical drill bit, single-use.

MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Sierra™ — SeaSpine Orthopedics Corporation · Class II
VersiTomic Low Profile Ø11.0 mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
APEX 3D S Total Ankle Replacement System — Paragon 28 · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Arthrex® — Arthrex, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Newdeal Sas

Sources (1)

FDA UDI 28de04f1-d26c-4c46-8413-4f43ed0ab1aa 36 fields · synced Jun 8, 2026