FDA.reportPublic FDA data

Elbow Immobilizer Pedo

Primary DI
D867ELISM0
Brand
Elbow Immobilizer Pedo
Company
Xemax Surgical Products Inc
Model
ELISM
Catalog number
ELISM
Device description
Elbow immobilizer with Velcro straps. Pedo size.
Published
2023-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D867ELISM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Elbow immobilizerA non-rigid device, usually made of a fabric, used to temporarily render the elbow immovable to support healing of an injury or a surgical wound. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
804495695
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D867CLEG0Etchant GelCLEGCLEG2017-05-22
D867CLEGS0Etchant Gel SyringeCLEGSCLEGS2017-05-22
D867CLABC0Aqua Bond CompositeCLABCCLABC2017-05-22
D867CLQSP0Quick Set Paste A & BCLQSPCLQSP2017-05-22
D867CLQSPA0Quick Set Paste ACLQSPACLQSPA2018-05-31
D867CLQSPB0Quick Set Paste BCLQSPBCLQSPB2018-05-31
D867RLH0Right Light RLHRLH2023-06-12
D867CLABP0Aqua Bond SealantCLABPCLABP2017-05-22
D867CSII1000C-SpongeIICSII1002022-08-08
D867CSIII1000C-SpongeIIICSIII1002022-08-08
D867CSIV1000C-SpongeIVCSIV1002022-08-08
D867CSP500C-SpongePedoCSP502022-08-08
D867CSR1000C-SpongeRegularCSR1002022-08-08
D867ELILG0Elbow ImmobilizerELILGELILG2023-06-12
D867OSSF0Osseo II Bone TrapOSSFOSSF2023-06-12
D867CL36005Cusp-Lok 360CL360052022-09-09
D867CL36010Cusp-Lok 360CL360102022-09-09
D867CLCMLP05Cusp-Lok CMLPCLCM05LP2022-09-09
D867CLCMLP10Cusp-Lok CMLPCLCM10LP2022-09-09
D867CLCMR05Cusp-Lok CMRCLCM05R2022-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
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00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327006MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327013MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
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00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
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00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327129MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327136MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327143MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327150MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327167MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327174MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327181MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327198MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327204MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327211MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
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00400000327235MEDIMEDI MANUFACTURING, INC.IQI2026-07-20