AccessGUDID - DEVICE: Sonopsy-C1 (04526737120041)

GUDID

Device Identifier (DI) Information

Brand Name: Sonopsy-C1
Version or Model: SON2150
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAKKO CO.,LTD.

Primary DI Number: 04526737120041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 693273427 *Terms of Use

Device Description: 1 21G x 50mm biopsy needle with suction syringe 3 Filter paper

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
FCG	Biopsy Needle Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013109	000

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
Needle Gauge: 21 Gauge
Length: 50 Millimeter

Device Record Status

Public Device Record Key: 1c29ff77-37e0-404d-b1f9-b7a5ccbd31ae
Public Version Date: June 03, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
14526737120048	5	04526737120041		In Commercial Distribution

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 513-271-2117
Email: SAst@havels.com

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