AccessGUDID - DEVICE: 8.5 x 50mm CANN EXTENSION FASTENER (00810097802056)

GUDID

Device Identifier (DI) Information

Brand Name: 8.5 x 50mm CANN EXTENSION FASTENER
Version or Model: 101-85050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101-85050
Company Name: Osteocentric Technologies, Inc.

Primary DI Number: 00810097802056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089645059 *Terms of Use

Device Description: 8.5 x 50mm CANN EXTENSION FASTENER

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?
46632	Endoscopic electrosurgical submucosal lift/resection set	A collection of devices designed to be used during an endoscopic mucosal resection procedure to: 1) lift a section of diseased mucosa by injection of a submucosal lifting solution; and 2) resect the lesion using monopolar electrosurgical energy; it may in addition include devices designed to perform vacuum elevation of the lesion to supplement submucosal lifting. It includes a submucosal injection needle, an electrosurgical electrode (e.g., polyp snare), and might include additional supportive devices such as a dye spray catheter and endoscope suction cap. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221332	000

Device Exempt from Premarket Submission: No 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
Outer Diameter: 8.5 Millimeter
Length: 50 Millimeter

Device Record Status

Public Device Record Key: e09108ad-40a0-408b-90c0-ae1aa7883cd0
Public Version Date: August 09, 2024
Public Version Number: 3
DI Record Publish Date: April 13, 2023