AccessGUDID - DEVICE: HALL OSTEON (30845854023215)

GUDID

Device Identifier (DI) Information

Brand Name: HALL OSTEON
Version or Model: 5038-002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00503800200
Company Name: Conmed Corporation

Primary DI Number: 30845854023215
Issuing Agency: GS1
Commercial Distribution End Date: May 27, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: HALL OSTEON ANGLED HANDPIECE

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?
37841	Surgical power tool system handpiece, sawing, pneumatic	A pneumatically-powered, hand-held device that consists of a motorized handpiece that provides sagittal, oscillating, or reciprocating movement for attachable serrated blades to cut through hard/tough tissue during surgery. The device may be of the micro or macro design and is typically powered by a compressed gas [e.g., surgical-grade air or nitrogen (N2)]. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GET	MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K833187	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
No Device Sizes

Device Record Status

Public Device Record Key: 503b27a1-6870-4394-ba67-92a3568e9fea
Public Version Date: May 28, 2021
Public Version Number: 2
DI Record Publish Date: September 02, 2020