AccessGUDID - DEVICE: AADCO (00840348500110)

GUDID

Device Identifier (DI) Information

Brand Name: AADCO
Version or Model: LA-9000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LA-9000
Company Name: AADCO MEDICAL, INC.

Primary DI Number: 00840348500110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 153603204 *Terms of Use

Device Description: 9" LASERX C-ARM IMAGE INTENSIFIER AIMER

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):	No
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?
36531	Aiming laser	A mains electricity (AC-powered) device assembly in which input energy is used to excite noble gas ions (e.g., helium/neon) to emit an easily visible, non-therapeutic low-level laser beam, intended to assist with aiming nonvisible therapeutic laser beam (e.g., carbon dioxide laser beam) during biostimulation and low-level therapies. Its principal emission wavelength is 633 nm (red), but it can also operate at other visible and infrared wavelengths; it may be operated in continuous and pulsed modes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWE	Monitor, Patient Position, Light-Beam

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: ee7808ce-49c5-420e-b024-170c4d4df96e
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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