AccessGUDID - DEVICE: BLACK & BLACK SURGICAL, INC. (00840329834128)

GUDID

Device Identifier (DI) Information

Brand Name: BLACK & BLACK SURGICAL, INC.
Version or Model: B8AX-MII-326 MLR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B8AX-MII-326 MLR
Company Name: BLACK & BLACK SURGICAL, INC.

Primary DI Number: 00840329834128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004382282 *Terms of Use

Device Description: MIRRORED ACCELERATOR POWER ASPIRATION CANNULA; 3MM X 26CM STRAIGHT

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):	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?
36107	Liposuction system cannula, single-use	A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEA	Cannula, Surgical, General & Plastic Surgery

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 314715ec-a796-408b-9bb1-15ad657b8b3b
Public Version Date: April 29, 2024
Public Version Number: 1
DI Record Publish Date: April 19, 2024