DEVICE: Sensory Cuff (00840252904066)

Device Identifier (DI) Information

Sensory Cuff
30223
In Commercial Distribution
30223
Therafin Corporation
00840252904066
GS1

1
056630924 *Terms of Use
CUFF, SENSORY LARGE PAIR (6"W X 18"L)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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?
45606 Compression/pressure shirt/pants
A garment in the form of a vest, shirt, pants, leggings, or whole-body suit intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to an area of the upper and/or mid/lower body to support skin/subcutaneous healing and scar prevention, to exude excessive interstitial fluid, and/or to help improve proprioception. It is a piece of clothing designed to be worn around the hips and/or shoulders, and is neither a strip/roll binder, limb sleeve, glove, nor sock. It is typically made of cotton or synthetic elastic material (e.g., Lycra); it does not include antimicrobial features. Absorbent pads may be used underneath the device. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KNM Device, Pressure Applying
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

95a55a39-60fb-46b7-a7eb-73ac64b48a00
July 14, 2023
1
July 06, 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

[?]
No
No
No
Yes
No CLOSE

Customer Contact

[?]
800-843-7234
Info@therafin.com
CLOSE