FDA.reportPublic FDA data

DONJOY

Primary DI
00190446752066
Brand
DONJOY
Company
DJO, LLC
Model
11-0021-6
Device description
PLAYMAKER II, X-ROM, XXL, BLACK
Published
2022-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITCSTIRRUP, EXTERNAL BRACE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITCStirrup, External Brace ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446752066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446752066001904467520661904467520660190446752066

GMDN Terms#

Term, Definition table
TermDefinition
Knee immobilizerA rigid support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446979128AIRCAST31M-9002026-08-03
00190446898610CMFMFUSE012026-07-31
00190446660590PROCARE155-79-871132026-07-31
00190446660606PROCARE155-79-871142026-07-31
00190446660613PROCARE155-79-871172026-07-31
00190446660620PROCARE155-79-871182026-07-31
00190446660637PROCARE155-79-870502026-07-31
00190446660644PROCARE155-79-870602026-07-31
00190446922490CMFMANAGEL012026-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20680651527121HalyardO&M HALYARD, INC.ITC2023-07-31
30680651527128HalyardO&M HALYARD, INC.ITC2023-07-31
00888912181754AIRCASTDJO, LLCITC2023-07-05
00888912181730AIRCASTDJO, LLCITC2022-11-14
00888912181761AIRCASTDJO, LLCITC2022-11-14
00888912199162DONJOYDJO, LLCITC2022-11-10
00888912217873DONJOYDJO, LLCITC2022-11-10
00888912217880DONJOYDJO, LLCITC2022-11-10
00888912217897DONJOYDJO, LLCITC2022-11-10
00888912217903DONJOYDJO, LLCITC2022-11-10
00888912217910DONJOYDJO, LLCITC2022-11-10