FDA.reportPublic FDA data

LEVEL ONE, STERILE

Primary DI
00888118079145
Brand
LEVEL ONE, STERILE
Company
KLS-Martin L.P.
Model
50-800-02-71
Device description
BATTERY PACK, FOR 50-800-0X-07, ALKALINE
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOQBATTERY, REPLACEMENT, RECHARGEABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOQBattery, Replacement, RechargeableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118079145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118079145008881180791458881180791450888118079145

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

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118086037SILICONE MAT55-348-01-012020-06-19
00888118125729TRAY55-804-25-012020-06-19
00888118003119CARRIER00-105-92-072018-09-26
00888118006974CURETTE01-500-01-072018-09-26
00888118006981CURETTE01-500-02-072018-09-26
00888118006998CURETTE01-500-03-072018-09-26
00888118008626CALIPER04-407-20-072018-09-26
00888118009012SCOPE HOLDER ARM07-001-42-072016-09-20
00888118009029SCOPE HOLDER CLAMP07-001-43-072016-09-20
00888118009050SCOPE HOLDER ARM07-001-49-072016-09-20
00888118022950PHLEBEXTRACTOR16-249-02-072018-09-26
00888118022967PHLEBEXTRACTOR16-249-03-072018-09-26
00888118022981STRIPPER16-251-02-012018-09-26
00888118022998STRIPPER16-251-03-012018-09-26
00888118023001STRIPPER16-251-04-012018-09-26
00888118023018STRIPPER16-251-06-012018-09-26
00888118023025STRIPPER16-251-07-012018-09-26
00888118023032STRIPPER16-251-08-012018-09-26
00888118023049STRIPPER16-251-10-012018-09-26
00888118023056STRIPPER16-251-14-012018-09-26

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30845854052079HALLConmed CorporationMOQ2026-04-01
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