FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00888912088671
Brand
DJO SURGICAL
Company
DJO, LLC
Model
803-00-033
Device description
CALCAR PLANER
Published
2023-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEOFILE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEOFile, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912088671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912088671008889120886718889120886710888912088671

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081840873
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15
00888912296977CHATTANOOGA28742016-09-15
00888912297110CHATTANOOGA28762016-09-15
00888912297295CHATTANOOGA28782016-09-15
00888912335652CHATTANOOGA39-07012016-09-15
00888912335669CHATTANOOGA39-07022016-09-15
00888912267588CHATTANOOGA20252026-03-31
00888912267618CHATTANOOGA20272026-03-31
00888912267625CHATTANOOGA20282026-03-31
00888912267632CHATTANOOGA20292026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05010058078598InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058084360InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058178595InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058184367InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-06-23
05010058081635InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-05-21
05010058181632InstrapacROBINSON HEALTHCARE LIMITEDGEO2025-05-21
G141514231000Carnegie Surgical LLCCarnegie Surgical LLCGEO2025-02-03
00888912088664DJO SURGICALDJO, LLCGEO2023-09-19
00840319735244Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735251Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735268Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735275Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735282Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735299Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735305Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735312Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735329Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319735336Hayden MedicalHayden Medical, Inc.GEO2023-03-17
00840319701447Hayden MedicalHayden Medical, Inc.GEO2022-07-22
10381780509448Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-10-23
H8344028020Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-10-23
00888118072481FILEKLS-Martin L.P.GEO2018-09-26
00888118085726FILEKLS-Martin L.P.GEO2018-09-26
10381780409731Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409748Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409755Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
10381780409762Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124811Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124861Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02
M274X5124911Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEO2018-05-02