AccessGUDID - DEVICE: AUTO LOCK TOURNIQUET (00192896090682)

GUDID

Device Identifier (DI) Information

Brand Name: AUTO LOCK TOURNIQUET
Version or Model: 1100-782
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1100-782
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896090682
Issuing Agency: GS1
Commercial Distribution End Date: July 25, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: AUTO LOCK TOURNIQUET

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):	Yes
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?
35844	Limb tourniquet, manual, reusable	A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It will typically have a fastening mechanism (e.g., Velcro or a self-locking buckle) that allows adjustments to the degree of tightness. This is a reusable device which may be intended for single- or multi-patient use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MWH	pulmonic valved conduit

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

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: acd4bde5-463b-42b5-a830-487f329672a1
Public Version Date: July 26, 2023
Public Version Number: 4
DI Record Publish Date: March 07, 2019