AccessGUDID - DEVICE: Philips (00884838118768)

GUDID

Device Identifier (DI) Information

Brand Name: Philips
Version or Model: 989603207974
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838118768
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grid, Upper dS Breast 16Ch I/T; 4 Medial Grid dS Breast 16CH I/T; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Block 14G; MRI Needle Block 16G; 2 Needle Block Holder; 2 Fiducial Marker Grid Block Assembly; 4 Lateral Grid, Lower dS Breast 16Ch I/T.

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:	No
Prescription Use (Rx):	No
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
60734	Needle guide, reusable	A non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PXP	Breast Biopsy / Localization Tray

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
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 927d6c0a-a0d6-4402-a242-60a23abc3a6a
Public Version Date: July 26, 2024
Public Version Number: 1
DI Record Publish Date: July 18, 2024