AccessGUDID - DEVICE: SDR TQH TMT Tourniquet & Holster Set (M689SDRTQH010)

GUDID

Device Identifier (DI) Information

Brand Name: SDR TQH TMT Tourniquet & Holster Set
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SDR TQH TMT
Company Name: Safeguard US Operating, LLC

Primary DI Number: M689SDRTQH010
Issuing Agency: HIBCC
Commercial Distribution End Date: June 02, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: 31-115 TMT Tourniquet 1 EA L01-003 3x1 blank polypropylene 1 EA L81-000 MARCH Bag Hang Tag 1 EA 89-115-BL TMT Holster Pouch 1 EA

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
35925	Tourniquet cuff, single-use	A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 81b59436-02e8-4d6c-9833-14e88c1b1f49
Public Version Date: June 15, 2022
Public Version Number: 1
DI Record Publish Date: June 07, 2022