AccessGUDID - DEVICE: N/A (00643169498105)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 27613
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC PS MEDICAL, INC.

Primary DI Number: 00643169498105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089055867 *Terms of Use

Device Description: LASER 27613 EXACTA W/SCREW ASSY

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
40893	Laser patient positioning system	A fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	DEVICE, MONITORING, INTRACRANIAL PRESSURE
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K983799	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55f482c6-b267-4c5a-aa69-36e23d5434cf
Public Version Date: October 17, 2022
Public Version Number: 3
DI Record Publish Date: September 23, 2015

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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