AccessGUDID - DEVICE: EG1™ (00845384018759)

GUDID

Device Identifier (DI) Information

Brand Name: EG1™
Version or Model: WIRELESS-HC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WIRELESS-HC
Company Name: Anspach Effort, The

Primary DI Number: 00845384018759
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079116867 *Terms of Use

Device Description: Wireless Hand Control, EG1A

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?
47864	Surgical power tool hand-switch	A handle-like device that is attached (clips or is slid onto the cylindrical barrel) to an electrically- or pneumatically-powered surgical power tool handpiece or motor of the micro types (a drill or a saw) so that the two devices interact to function as a switch used by the operating surgeon to hand activate (start and stop) the handpiece/motor. It is typically made of metal and/or synthetic materials and will typically include a sliding lock that, when brought into use by the surgeon, will lock the handle in the "On" position. 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 [?]
K220485	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -20 and 140 Degrees Fahrenheit
Special Storage Condition, Specify: Do not use if package is damaged

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c094402-f5f4-45f3-a834-78cb43af2869
Public Version Date: July 18, 2022
Public Version Number: 1
DI Record Publish Date: July 08, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)255-2500
Email: RA-DPYNA-anspachpowe@its.jnj.com

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