AccessGUDID - DEVICE: Ultra-Pro e™ Variable Angle Needle Guide (10841436102213)

GUDID

Device Identifier (DI) Information

Brand Name: Ultra-Pro e™ Variable Angle Needle Guide
Version or Model: 610-1135
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 610-1135
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 10841436102213
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover

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):	Yes
Over the Counter (OTC):	No
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?
45018	Needle guide, single-use	A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, imaging, pulsed echo, ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093713	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight
Storage Environment Temperature: between 52 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 1.6 Inch
Height: 1.3 Inch

Device Record Status

Public Device Record Key: a81c49cc-7322-41ff-819d-d6b92519b061
Public Version Date: February 16, 2024
Public Version Number: 10
DI Record Publish Date: August 22, 2017