FDA.reportPublic FDA data

NA

Primary DI
34546540604119
Brand
NA
Company
STRYKER CORPORATION
Model
5400702000
Catalog number
5400702000
Device description
The Mill Disposable - Fine
Published
2018-09-24
Public version status
New
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
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540604119PackageGS15In Commercial Distribution
04546540604118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654060411934546540604119
04546540604118045465406041184546540604118

GMDN Terms#

Term, Definition table
TermDefinition
Powered bone mill cartridgeA sterile cutting device intended to be powered by a bone mill motor to create particles of bone autografts (i.e., bone harvested from and transplanted into the same patient) for implantation during a bone regeneration or bone grafting procedure. It typically consists of a cutting disc, a plunger, and collection drawer. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

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
true
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
00810111227148K-WireTreace Medical Concepts, Inc.HWE2026-03-23
10885862661555N/AExactech, Inc.HWE2026-03-19
00888867529762Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529779Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529809Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529830Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529847Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531628Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531635Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531680Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531727Arthrex®ARTHREX, INC.HWE2026-03-16
09421038412145Cup reamer handle, offset, Z/H, lockingENZTEC LIMITEDHWE2026-03-09
09421038412152Offset coupling, Z/HENZTEC LIMITEDHWE2026-03-09
09421038412169Offset drive train, lockingENZTEC LIMITEDHWE2026-03-09
09421038412176Short Offset Cover – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412183Handle – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412299Cup reamer handle, offset, AO, lockingENZTEC LIMITEDHWE2026-03-09
09421038412305Offset coupling, AOENZTEC LIMITEDHWE2026-03-09
09421038412312Cup reamer handle, offset, AO, openENZTEC LIMITEDHWE2026-03-09
09421038412329Offset drive train, openENZTEC LIMITEDHWE2026-03-09
09421038412671Cup reamer handle, offset, Z/H, openENZTEC LIMITEDHWE2026-03-09
00810111225601ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225618ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225625ReamerTreace Medical Concepts, Inc.HWE2026-03-02
09421038411865Enztec Modular OCI XENZTEC LIMITEDHWE2026-02-27
09421038412138Enztec Modular OCI XRENZTEC LIMITEDHWE2026-02-27
00888867536746Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536760Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536777Arthrex®ARTHREX, INC.HWE2026-02-25
09421038412725Enztec Reamer 36mm - BridgebackENZTEC LIMITEDHWE2026-02-23