Integra® Miltex®

Integra® Miltex® Stille Pattern Cranial Drill Set: Drill, 2.5mm-4mm twist drills, 5mm-16mm burrs & 1 trephine 10mm

Registry build 21.09.26
2manufacturers in China registered for this device type
65catalogue numbers in this listing

Who Else Makes It

All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HBG
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Shanghai Wilpower Industrial Co., Ltd. Shanghai Shanghai Exporter 33

Record

Regulatory record for Integra® Miltex®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code HBG
Device type Drills, Burrs, Trephines & Accessories (Manual)
Device class Class 2
Regulation 21 CFR 882.4300
Establishment Contract manufacturer, Specification developer, Manufacturer
Record published 2016-08-03
Record revised 2026-05-28 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Sizes Length 6 to 9 in; width 1 in; outer diameter 5 to 8 mm; width 27.7 to 28 mm
Distribution end date 2022-05-01

Catalogue Numbers

Catalogue numbers for Integra® Miltex®
Catalogue number Size Status
26-46-4 In distribution
26-44-2 In distribution
11-634-SH In distribution
MH11-630-SH In distribution
MH11-366 In distribution
MH11-630-BL In distribution
11-654 7-3/4″ In distribution
26-266 4mm Bite In distribution
11-650 7-3/4″ In distribution
26140 Length 6 in In distribution
26-256 In distribution
26-255 In distribution
26-190 In distribution
26-262 In distribution
26-2 In distribution
MH11-365 In distribution
26-46-1 In distribution
26463 In distribution
11-634-BL In distribution
11-686 Width 27.7 mm In distribution
11-700 In distribution
26-30 In distribution
26-192 In distribution
11-630-SH In distribution
26-141 Outer Diameter 6 mm In distribution
11-642-BL In distribution
11-630-BL In distribution
26-33-1 In distribution
11-702 In distribution
MH11-364 In distribution
26-220 In distribution
MH11-702 In distribution
26-264 In distribution
26-40 In distribution
26-261 In distribution
11-642-SH In distribution
11-656 7-3/4″ In distribution
11-652 7-3/4″ In distribution
26-1973 In distribution
26-20 In distribution
26-16 In distribution
26-33-4 In distribution
MH11-684 In distribution
26-18 In distribution
26-44-3 In distribution
11-10 In distribution
11-365 In distribution
26-142 Length 6 in In distribution
V911-366 In distribution
26-2000 In distribution
11-366 In distribution
26-265 In distribution
26-143 2-1/2″ In distribution
26-33-2 In distribution
11-684 Width 28 mm In distribution
26-2005 In distribution
26-222 In distribution
26-2001 In distribution
26-44-4 In distribution
26-33-3 In distribution
MH11-700 In distribution
26-44-1 In distribution
26-258 Withdrawn
26-46-2 Withdrawn
26-200 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 508
Integra® Jarit® Integra LifeSciences Production Corporation 172
Drills, Burrs, Trephines & Accessories (Manual) Synthes Gmbh 34
Integra® Integra Pain Management 7
Symmetry Surgical Aspen Surgical Products, Inc. 6
Symmetry Hudson Aspen Surgical Products, Inc. 5
Symmetry Cushing Aspen Surgical Products, Inc. 4
V. Mueller Steris Corporation 3
SmartTip ClearPoint Neuro Inc. 3
Drill Bit Neurovention, LLC 2
Codman® Integra LifeSciences Production Corporation 2
Disposable Drill Kit AD-Tech Medical Instrument Corp. 2

Showing 12 of 41. All products under Drills, Burrs, Trephines & Accessories (Manual)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer