AccessGUDID - DEVICE: Sheathes3D (10842418100838)

GUDID

Device Identifier (DI) Information

Brand Name: Sheathes3D
Version or Model: 73459
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SHEATHING TECHNOLOGIES, INC.

Primary DI Number: 10842418100838
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 806806220 *Terms of Use

Device Description: Seamless Viral Barrier, Polyurethane, 1.18"D x 8"L, Non-Sterile, Ultrasound Probe Cover with 5" Debris Shield, Vaginal/Rectal, Tapered, Bi-Directionally Rolled, Individually Wrapped

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):	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?
60609	Body-orifice ultrasound imaging transducer cover, basic, non-sterile	A non-sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153212	000

Device Exempt from Premarket Submission: No 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: 49afaab1-4266-4ca2-8966-944b41d682c8
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 22, 2016