AccessGUDID - DEVICE: Battery Pack, Single Use, PDCMF, Tadiran (00856482008283)

GUDID

Device Identifier (DI) Information

Brand Name: Battery Pack, Single Use, PDCMF, Tadiran
Version or Model: PDCMF-BP-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRO-DEX, INC.

Primary DI Number: 00856482008283
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 849370358 *Terms of Use

Device Description: No description.

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?
48058	Disposable battery pack	A group of battery cells (e.g., lithium ion cells) held within a container that is sterile used to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. This device is typically designed to power cordless surgical power tools (e.g., a non-rechargeable battery-powered surgical drilling system handpiece) and is non-rechargeable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEY	Motor, Surgical Instrument, Ac-Powered
GXL	Screwdriver, Skullplate

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b04d1a9d-b241-489e-90ef-b4b6e1469a81
Public Version Date: December 19, 2024
Public Version Number: 2
DI Record Publish Date: April 01, 2022