AccessGUDID - DEVICE: STERLING SOUTHPAW (10845854036563)

GUDID

Device Identifier (DI) Information

Brand Name: STERLING SOUTHPAW
Version or Model: MC9106
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MC9106
Company Name: Conmed Corporation

Primary DI Number: 10845854036563
Issuing Agency: GS1
Commercial Distribution End Date: June 04, 2024
Device Count: 6
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 6.0MM STERLING, OVAL BUR, SOUTHPAW, SMALL HUB

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?
41499	Arthroscopic shaver system blade, single-use	A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFF	BUR, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f973adc7-24b6-491a-ab78-388d8ac4c61e
Public Version Date: June 05, 2024
Public Version Number: 4
DI Record Publish Date: October 13, 2021