DEVICE: ATEC Needle Guide (05420045503123)

Download: XML | JSON

Device Identifier (DI) Information

ATEC Needle Guide
ATEC NG12-LORAD
ATEC NG12-LORAD
Hologic, Inc.
05420045503123
GS1
1
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Side-notch biopsy gun, single-use A sterile hand-operated surgical instrument designed for the automatic extraction of a small tissue sample from an anatomic structure of the body (i.e., a biopsy), while causing minimal surrounding tissue damage, for pathological examination/testing. It has a spring-loaded mechanism intended for transcutaneous insertion of its distal needle-like portion. It typically has a trocar-like distal tip with a side-notch cutter; when activated, a sharp, sliding cannula slices a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KNW INSTRUMENT, BIOPSY
CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Radiation Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 03, 2015

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15420045503120 5 05420045503123 In Commercial Distribution BOX
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE