AccessGUDID - DEVICE: EG1™ High Speed System (00845384016526)

GUDID

Device Identifier (DI) Information

Brand Name: EG1™ High Speed System
Version or Model: XL-HD-G1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XL-HD-G1
Company Name: Synthes GmbH

Primary DI Number: 00845384016526
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: 20.2 cm Heavy Duty X-Long Attachment, G1

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?
43555	Burring power tool attachment	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERL	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HBC	MOTOR, DRILL, ELECTRIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133604	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
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 48e46ab7-790e-4f70-b1ff-a1f0e02a5827
Public Version Date: June 12, 2025
Public Version Number: 3
DI Record Publish Date: May 05, 2021