FDA.reportPublic FDA data

NA

Primary DI
07611819302235
Brand
NA
Company
Synthes GmbH
Model
03.100.039
Catalog number
03100039
Device description
CURVED PELVIC OSTEOTOME 20MM WIDTH
Published
2016-12-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819302235Direct MarkingGS10
10886982070883PrimaryGS10
H679031000390SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819302235076118193022357611819302235
1088698207088310886982070883

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
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
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811099624INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811110442INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811111289INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
10381780503316Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503323Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503330Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503347Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503354Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10603295080770NADEPUY (IRELAND)HWM2018-09-24
10603295080787NADEPUY (IRELAND)HWM2018-09-24
10603295080794NADEPUY (IRELAND)HWM2018-09-24
10603295083160SIGMADEPUY (IRELAND)HWM2018-09-24
10603295083191SIGMADEPUY (IRELAND)HWM2018-09-24
10603295090403GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090410GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090427GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090434GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090441GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090458GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295122739NADEPUY (IRELAND)HWM2018-09-24
10603295122746NADEPUY (IRELAND)HWM2018-09-24
10603295122753NADEPUY (IRELAND)HWM2018-09-24
10603295122760NADEPUY (IRELAND)HWM2018-09-24
10603295122777NADEPUY (IRELAND)HWM2018-09-24
10603295122784NADEPUY (IRELAND)HWM2018-09-24
10603295122791NADEPUY (IRELAND)HWM2018-09-24
10603295123071MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123088MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123095MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123101MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24