FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327320176
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
I-H1552HA40
Catalog number
I-H1552HA40
Device description
SPECIALTY THREADED DRILL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327320176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327320176076133273201767613327320176

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length40Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862660824NovationExactech, Inc.LWJ2026-03-19
10885862661005N/AExactech, Inc.LWJ2026-03-19
10885862661067N/AExactech, Inc.LWJ2026-03-19
10885862661081N/AExactech, Inc.LWJ2026-03-19
10885862661098N/AExactech, Inc.LWJ2026-03-19
10885862658173EXACTECHExactech, Inc.LWJ2025-11-14
10885862658272EXACTECHExactech, Inc.LWJ2025-11-14
10885862658296EXACTECHExactech, Inc.LWJ2025-11-14
10885862658302EXACTECHExactech, Inc.LWJ2025-11-14
04719886904666U-Motion IIUNITED ORTHOPEDIC CORP.LWJ2025-09-15
04719886904673U-Motion IIUNITED ORTHOPEDIC CORP.LWJ2025-09-15
10885862653246NovationExactech, Inc.LWJ2025-05-15
00887868575563Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575600Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575624Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575655Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575723Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575822Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575907Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868576027Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868576133Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868576164Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868577116Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868577888Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868578540Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868578557Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00889024655904Fitmore® Hip StemZimmer GmbHLWJ2023-02-23
07613327460254INSTRUMENTHowmedica Osteonics Corp.LWJ2022-12-20
10885862030948NAExactech, Inc.LWJ2022-10-04
10885862030962NAExactech, Inc.LWJ2022-10-04