FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00888912126991
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
800-04-085
Device description
MOV BOX CHISEL SZ 2 - 6
Published
2024-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMLCHISEL, BONE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912126991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912126991008889121269918889121269910888912126991

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154074504
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
00888912024952DJO SURGICAL520-01-2422017-08-07
00190446356820DJO SURGICAL800-02-5062021-02-12
00190446839187DJO SURGICAL804-06-4182024-06-27
00190446839194DJO SURGICAL804-06-4192024-06-27
00190446839200DJO SURGICAL804-06-3182024-06-27
00190446839217DJO SURGICAL804-06-3192024-06-27
00888912024884DJO SURGICAL520-00-0002017-08-07
00190446263906DJO SURGICAL354-10-0402018-07-16
00190446264156DJO SURGICAL354-10-0652018-07-16
00190446264163DJO SURGICAL354-12-0402018-07-16
00190446264170DJO SURGICAL354-12-0652018-07-16
00190446264187DJO SURGICAL354-14-0402018-07-16
00190446264194DJO SURGICAL354-14-0652018-07-16
00190446978213DJO SURGICALS-2019692026-05-01
00190446978268DJO SURGICALS-2019702026-05-01
00190446978275DJO SURGICALS-2019712026-05-01
00190446978282DJO SURGICALS-2019722026-05-01
00888912078634DJO SURGICAL425-97-0052017-08-07
00888912078641DJO SURGICAL425-97-0062017-08-07
00888912078658DJO SURGICAL425-97-0072017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783012316Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEML2026-04-02
00840018672505Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672666Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672970Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018674189Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018667396Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-10
00840018665682Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018666030Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018663732Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665491Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665507Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018661202Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661219Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661226Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661233Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661240Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00194613013448MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013479MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013486MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
D92820001580BAUER GUARDED OSTEO 8MM STRW.H. Holden, Inc.EML2025-05-21
00194613013462MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613104290MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613108601MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00888912127028DJO SURGICALEncore Medical, L.P.EML2024-08-22
00887482050606Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.EML2024-08-12
00813677023254PDT, Inc.PDT, INC.EML2024-07-01
00813677023261PDT, Inc.PDT, INC.EML2024-07-01
00888912088725DJO SURGICALDJO, LLCEML2024-05-20
00842517105652Karl SchumacherKarl Schumacher Dental, LLCEML2024-05-06
00842517105669Karl SchumacherKarl Schumacher Dental, LLCEML2024-05-06