FDA.reportPublic FDA data

Turtlebrace

Primary DI
30628634832098
Brand
Turtlebrace
Company
9321-8758 Québec Inc
Model
Wrist Adult with zipper closure
Catalog number
TBPAZ-01, TBPAZ-02,TBPAZ-03
Device description
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace with zipper closure.Size small (01), medium (02), or large (03), Adult (ADU)
Published
2023-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
30628634832098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3062863483209830628634832098

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made upper-limb orthosisAn externally-applied wearable appliance constructed with specific characteristics (e.g., size, shape, material), as prescribed by a healthcare provider for a specified patient (custom-made), intended to support and correct deformities of the arm and/or hand. It may be one of numerous different designs and is typically made of synthetic and textile materials. This is a single-patient reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
(819) 473-0657info@turtlebrace.com

Regulatory Flags#

DUNS number
203875315
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10628634832018TurtlebraceAnkle Baby TBBC-01, TBBC-02, TBBC-032023-01-16
10628634832162TurtlebraceElbow Baby TBBCo-01, TBBCo-02, TBBCo-03, TBBCo-042023-01-16
20628634832039TurtlebraceAnkle PediatricTBCP-01, TBCP-02,TBCP-032023-01-16
20628634832046TurtlebraceAnkle Pediatric ReinforcedTBCPR-02, TBCPR-032023-01-16
20628634832077TurtlebraceWrist Pediatric with zipper closureTBPPZ-02,TBPPZ-032023-01-16
20628634832084TurtlebraceWrist Pediatric with velcro closureTBPPV-02,TBPPV-032023-01-16
20628634832145TurtlebraceWrist Pediatric HBPP-02,HBPP-032023-01-16
20628634832176TurtlebraceElbow Pediatric TBCoP-01, TBCoP-02, TBCoP-03, TBCoP-042023-01-16
30628634832050TurtlebraceAnkle AdultTBCA-01, TBCA-02, TBCA-032023-01-16
30628634832067TurtlebraceAnkle Adult ReinforcedTBCAR-01, TBCAR-02, TBCAR-032023-01-16
30628634832104TurtlebraceWrist Adult with velcro closureTBPAV-01, TBPAV-02,TBPAV-032023-01-16
30628634832159TurtlebraceWrist AdultHBPA-01, HBPA-02,HBPA-032023-01-16
30628634832180TurtlebraceElbow AdultTBCoA-01, TBCoA-02, TBCoA-032023-01-16
80628634832116TurtlebraceUniversal Fingers AttachementEDUA2023-01-16
80628634832123TurtlebraceUniversal Thumb AttachementEPUA2023-01-16
80628634832130TurtlebraceUniversal FingerDUA2023-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257215913MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215920MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
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00636257215951MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215968MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00190446660590PROCAREDJO, LLCIQI2026-07-31
00190446660606PROCAREDJO, LLCIQI2026-07-31
00190446660613PROCAREDJO, LLCIQI2026-07-31
00190446660620PROCAREDJO, LLCIQI2026-07-31
00190446660637PROCAREDJO, LLCIQI2026-07-31
00190446660644PROCAREDJO, LLCIQI2026-07-31
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
00810178883134ViveVIVE HEALTH LLCIQI2026-07-21
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
00400000327075MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327099MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20