FDA.reportPublic FDA data

NA

Primary DI
04546540466440
Brand
NA
Company
STRYKER CORPORATION
Model
1605012010
Catalog number
1605012010
Device description
Diamond Round
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540466440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540466440045465404664404546540466440

GMDN Terms#

Term, Definition table
TermDefinition
Diamond ENT bur, single-useA rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551366583Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366590Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366606Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366613Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
B775635CK0PHASORPHASOR HEALTH LLCHBE2026-01-19
B7752IN125LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN145LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1256LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7755IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDBA0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDRI0PHASORPHASOR HEALTH LLCHBE2025-11-24
00763000679682POWEREASE™ InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HBE2025-07-28
00763000683511POWEREASE™ InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HBE2025-07-27
00763000722388MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-25
00763000722319ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-25
00763000722418MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-21
00763000988784Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-17
00763000892722Midas Rex ClearviewMEDTRONIC XOMED, INC.HBE2025-06-23
06429811532069Surgify Halo | 4.0 mm | ShortSurgify Medical OyHBE2025-06-18
06429811532076Surgify Halo | 4.0 mm | ExtendableSurgify Medical OyHBE2025-06-18
06429811532083Surgify Halo | 4.0 mm | LongSurgify Medical OyHBE2025-06-18
15059358034986ZethonZETHON LIMITEDHBE2025-05-14
05059358036457ZethonZETHON LIMITEDHBE2025-05-14
15059358036478ZethonZETHON LIMITEDHBE2025-05-14