FDA.reportPublic FDA data

BATTERY PACK, KLS-SD-2000, SINGLE

Primary DI
10856482008129
Brand
BATTERY PACK, KLS-SD-2000, SINGLE
Company
PRO-DEX, INC.
Model
KLS-BP2-001
Published
2022-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856482008129PackageGS140In Commercial Distribution
00856482008122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085648200812910856482008129
00856482008122008564820081228564820081220856482008122

GMDN Terms#

Term, Definition table
TermDefinition
Disposable battery packA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
849370358
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856482008122BATTERY PACK, KLS-SD-2000, SINGLEKLS-BP2-0012022-03-29
00860540000218MatrixPro Sterilization Case Lid60.000.0112022-03-28
00856482008252Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)PDCMF-1000-12022-04-01
00856482008283Battery Pack, Single Use, PDCMF, TadiranPDCMF-BP-0012022-04-01
00856482008016KLS E-Coupling Adapter PDEC-1000-32022-03-29
00856482008115KLS MaxDriver 2 KLS-SD-20002022-03-29
00856482008207Pro-Dex Surgical Driver PDSD-5000-12022-03-29
00856482008214Pro-Dex Surgical Driver AO Collet PDSD-5000-22022-03-29
00856482008290Pro-Dex Surgical Driver Custom Collet PDSD-5000-52022-03-29
00860540000256ProDriver Battery Pack, SinglePDBP-001-22022-03-29
00862377000119MatrixPRO Driver Battery Pack, Sterile05.000.021S2022-03-23
00856482008009Atlas Pro Driver Battery Pack, SterileAPD-BP-001S-12020-03-13
00860540000201MatrixPro sterilization case60.000.0102020-03-27
00856482008108Matrix Pro II Graphics case60.000.0152020-03-11
00856482008436Zimmer Biomet Atlas Pro DriverAPD-1000-42023-06-09
00856482008269MatrixPRO II Handpiece Loaner05.000.030LN2022-04-01
00860540000225MatrixPRO Driver Loaner05.000.020LN2022-04-01
00856482008245Pro-Dex Surgical Driver Medicon PDSD-5000-62022-03-29
00862377000188KLS Martin Surgical Driver, Non-Torque LimitingKLS-SD-1000-NTL2022-03-29
00862377000133KLS MARTIN SURGICAL DRIVERKLS-SD-10002022-03-28

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