FDA.reportPublic FDA data

CoreTech

Primary DI
10810041980639
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP2040BLKM
Device description
3907 Thumb Spica (Left) Medium
Published
2023-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041980639PackageGS150In Commercial Distribution
00810041980632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198063910810041980639
00810041980632008100419806328100419806320810041980632

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, reusableA prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178889280CoreTechSUP3128BLKS2026-05-05
00810178889297CoreTechSUP3128BLKM2026-05-05
00810178889303CoreTechSUP3128BLKL2026-05-05
00810178889310CoreTechSUP3128BLKXL2026-05-05
00810178889327CoreTechSUP3128BLK2XL2026-05-05
00810226442306ViveDMD1087CUFF2026-08-25
00810226442245ViveCSH1116GRY2026-08-21
00810226442290ViveLVA3188BLK2026-08-21
00810178889648CoreTechSUP3156BLK2026-08-19
00810178889655ViveMOB1162BLK2026-08-19
00810178889662ViveMOB1162DBU2026-08-19
00810178889679ViveMOB1162TAL2026-08-19
00810226442016ViveLVA3187BLU422026-08-19
00810226442023ViveLVA3187BLU482026-08-19
00810226442030ViveLVA3187BLU542026-08-19
00810226441965ViveLVA3184BLK2026-08-14
00810226441972ViveLVA3184BLK2PAK2026-08-14
00810226441989ViveLVA3185BLK2026-08-14
00810178887743ViveRHB3076M2026-08-07
00810041980229ViveSUP1064TAL2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226441538ViveVIVE HEALTH LLCITQ2026-08-03
00049696508377THERA PlusFOURSTAR GROUP INC.ITQ2026-06-09
00810178889280CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889297CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889303CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889310CoreTechVIVE HEALTH LLCITQ2026-05-05
00810178889327CoreTechVIVE HEALTH LLCITQ2026-05-05
00057475210434BIOS LivingThermor LtdITQ2023-03-31
0060927120013516'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610842"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610859"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (xx-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08