FDA.reportPublic FDA data

Dobbs

Primary DI
00850028600016
Brand
Dobbs
Company
D-Bar Enterprises, LLC
Model
QDCB-SM
Device description
Quick Release Dobbs Bar w/ Spring Reset - Small Size (6 Inch thru 9 Inch)
Published
2021-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITNSPLINT, DENIS BROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITNSplint, Denis BrownPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850028600016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028600016008500286000168500286000160850028600016

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisAn externally-applied appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds. It is made of metal, synthetic, and/or textile materials and may include customizable plantar inserts. This is a single-patient use device that can be reapplied to the patient during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078373095
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850028600023DobbsQDCB-REG2021-04-17
00850028600030DobbsSDCBMD-SM2021-04-17
00850028600047DobbsSDCBMD-REG2021-04-17
00850028600054DobbsDCB-SM2021-04-17
00850028600061DobbsDCB-REG2021-04-17
00850028600078DobbsEZCLK-SM2021-04-17
00850028600085DobbsEZCLK-REG2021-04-17
00850028600092DobbsEZCLKMD-SM2021-04-17
00850028600108DobbsEZCLKMD-REG2021-04-17
00850028600115DobbsQDCB2.02021-04-17
00850028600122DobbsSDCBMD2.02021-04-17
00850028600139DobbsIADCB-SM2021-04-17
00850028600146DobbsIADCB-REG2021-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112622Sonosite STFUJIFILM SONOSITE, INC.ITN2026-05-01
00810060888438Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.ITN2026-03-12
00810060888407Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2024-01-17
00810060883365Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883372Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883389Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883396Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883402Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883419Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883426Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883433Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883440Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883457Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883464Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883471Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060880166Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880197Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880203Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880210Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880227Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880234Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880241Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880258Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880265Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880272Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880289Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880296Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880005Mitchell Ponseti® Move BarMD ORTHOPAEDICS, INC.ITN2023-03-22
00810060880012Mitchell Ponseti® Move BarMD ORTHOPAEDICS, INC.ITN2023-03-22
00810060880029Mitchell Ponseti® Move BarMD ORTHOPAEDICS, INC.ITN2023-03-22