FDA.reportPublic FDA data

Unite Medical®

Primary DI
00850012035619
Brand
Unite Medical®
Company
Unite Medical, LLC
Model
Heel Stabilizer (Small)
Catalog number
HS3170-S
Device description
The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.
Published
2023-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012035619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012035619008500120356198500120356190850012035619

GMDN Terms#

Term, Definition table
TermDefinition
Heel stirrup cushion/padA pad designed to be placed between a patient's foot and a table heel stirrup, cushioning the patient's heel and lower leg to provide greater comfort and to reduce the risk of sores during long procedures. The device is typically made of soft material (e.g., foam) with an appropriate shape and size to fit the heel stirrup; it is usually supplied in pairs. The device is used mainly for patients in lithotomic position for obstetrical, urological, colonic, or rectal procedures. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833.868.6483info@unitemedical.net

Regulatory Flags#

DUNS number
117553945
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063323550RegeniCool™ ProRC-PRO-1000RC-PRO-10002026-03-13
00850063323567RegeniCool™ ProRC-PRO-1000RC-PRO-10002026-03-13
00850012035312Unite Medical®Cryo Pneumatic Shoulder - UniversalCyro36702024-06-20
00850012035626Unite Medical®Heel Stabilizer (Medium)HS3170-M2023-12-28
00850012035633Unite Medical®Heel Stabilizer (Large)HS3170-L2023-12-28
00850012035640Unite Medical®Heel Stabilizer (XLarge)HS3170-XL2023-12-28
00850052096915Unite Medical®Tall Walking Boot - Pneumatic (XSmall)PWB6061-XS-T2024-06-20
00850052096922Unite Medical®Tall Walking Boot - Pneumatic (Small)PWB6061-S-T2024-06-20
00850052096939Unite Medical®Tall Walking Boot - Pneumatic (Medium)PWB6061-M-T2024-06-20
00850052096946Unite Medical®Tall Walking Boot - Pneumatic (Large)PWB6061-L-T2024-06-20
00850052096953Unite Medical®Tall Walking Boot - Pneumatic (XLarge)PWB6061-XL-T2024-06-20
00850063323000Unite Medical®Short Walking Boot - Pneumatic (XLarge)PWB6061-XL-S2024-06-20
00850063323017Unite Medical®Short Walking Boot - Pneumatic (Large)PWB6061-L-S2024-06-20
00850063323024Unite Medical®Short Walking Boot - Pneumatic (Medium)PWB6061-M-S2024-06-20
00850063323031Unite Medical®Short Walking Boot - Pneumatic (Small)PWB6061-S-S2024-06-20
00850063323048Unite Medical®Short Walking Boot - Pneumatic (XSmall)PWB6061-XS-S2024-06-20
00850012035121Unite Medical®Universal ROM Knee BraceKO32332023-12-28
00850012035138Unite Medical®Deluxe Universal ROM Knee BraceKO3233-12023-12-28
00850012035244Unite Medical®Single Upright Knee Orthosis (Left, Universal)KO4351L2023-12-28
00850012035251Unite Medical®Single Upright Knee Orthosis (Right, Universal)KO4351R2023-12-28

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