AccessGUDID - DEVICE: DIEGO (00821925042360)

GUDID

Device Identifier (DI) Information

Brand Name: DIEGO
Version or Model: 70339000R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gyrus ACMI, LLC

Primary DI Number: 00821925042360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007198742 *Terms of Use

Device Description: DIEGO POWER DISSECTOR REFURBISHED CONSOLE TRIGGER SWITCH ENABLED

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?
41589	ENT shaver system	An assembly of mains electricity (AC-powered) devices designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It typically consists of a power supply transformer/control unit with operational controls, setting display, electrical connecting cables, and a rotary handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotary instruments. Some types may have dedicated software intended to provide optimal parameters for the procedure. An irrigation/suction system may be included.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020594	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: 8649d090-a3bf-4802-a3ef-7bf89334353e
Public Version Date: September 02, 2024
Public Version Number: 5
DI Record Publish Date: October 06, 2016

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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