AccessGUDID - DEVICE: ACHIEVE (10885403222313)

GUDID

Device Identifier (DI) Information

Brand Name: ACHIEVE
Version or Model: ACA1815
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ACA1815
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403222313
Issuing Agency: GS1
Commercial Distribution End Date: October 27, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: ACHIEVE NEEDLE BIOP 18GX15CM ADJ COAXIAL

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:	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?
47540	Soft-tissue biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GDF	GUIDE, NEEDLE, SURGICAL
KNW	INSTRUMENT, BIOPSY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Length: 15 Centimeter
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: c46bbbf5-556e-4313-9e85-24dcbbe123c6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016