AccessGUDID - DEVICE: ActiSplint with Sensi-Wrap (00616784353333)

GUDID

Device Identifier (DI) Information

Brand Name: ActiSplint with Sensi-Wrap
Version or Model: 3533
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784353333
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wrap; Combo Packs

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43565	Arm splint system, self-moulding	A collection of non-sterile devices designed to produce a moulded splint that is formed around the upper limb of a patient who requires support or immobilization (e.g., to treat fractures, injuries, strains, sprains). It typically consists of a two-component polyurethane that is mixed and poured into a textile which matches this part of the body creating a rigid or soft foam splint that is applied to the patient’s arm where it sets. It is available in different sizes. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile
KGX	Tape And Bandage, Adhesive

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9e1f5e7-645d-45e4-9c14-1f5061b6b583
Public Version Date: October 09, 2024
Public Version Number: 2
DI Record Publish Date: September 01, 2021