AccessGUDID - DEVICE: Extremity Care (00850003042398)

GUDID

Device Identifier (DI) Information

Brand Name: Extremity Care
Version or Model: ALC400S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Extremity Care

Primary DI Number: 00850003042398
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086365085 *Terms of Use

Device Description: Cannula Kit Basket w/Scalpel Kit Includes: Primary DI: 00850003042381 Version: ALC425 Device Description: Basket Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Basket Cannula Tube ID:2.5mm, OD:3.0mm Primary DI: 00850003042299 Version: ATL400 Device Description: Thumb Scalpel (#11)

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?
46676	Tissue injection cannula	A thin, sterile, semi-rigid or rigid metal tube intended to be inserted percutaneously for the injection of a substance into the cutaneous or subcutaneous layers. It is typically used for the administration of fillers [e.g., hyaluronic acid (HA)] to add volume to tissue for cosmetic or reconstructive purposes. The device is typically designed with a closed-off nose and a lateral hole at the distal tip, and a connector at the proximal end for attachment to a device that propels the injection substance. It is typically made of high-grade stainless steel. This is a single-use device.	Active	false
37445	Manual scalpel blade, single-use	An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEA	Cannula, Surgical, General & Plastic Surgery
GES	Blade, Scalpel

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ceca222b-68f7-46f0-964f-5ff847637404
Public Version Date: February 14, 2024
Public Version Number: 1
DI Record Publish Date: February 06, 2024