DEVICE: Unite Medical® (00850012035640)

Device Identifier (DI) Information

Unite Medical®
Heel Stabilizer (XLarge)
In Commercial Distribution
HS3170-XL
Unite Medical, LLC
00850012035640
GS1

1
117553945 *Terms of Use
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.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35547 Heel stirrup cushion/pad, reusable
A 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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ITW Joint, Ankle, External Brace
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

edd22ede-8609-4d45-8dc7-febbfe41a6c2
August 07, 2024
2
December 28, 2023
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
833.868.6483
info@unitemedical.net
CLOSE