Biomet SpinalPak / OrthoPak 106130-20

GUDID 00812301020201

Patient-worn bone growth electromagnetic stimulator

Primary Device ID	00812301020201
NIH Device Record Key	8ca71cc5-5d8a-4fdf-9d0c-6e43c64b0cb4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Biomet SpinalPak / OrthoPak
Version Model Number	106130-20
Catalog Number	106130-20
Company DUNS	050410323
Company Name	EBI, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00812301020201 [Primary]

LOF	Stimulator, Bone Growth, Non-Invasive

Steralize Prior To Use	false
Device Is Sterile	false

00812301020393	AC ADAPTOR, ALTERNATE
00812301020386	AC ADAPTER KIT
00812301020379	WALL PLUG ADAPTER KIT
00812301020362	AC ADAPTOR, REPLACEMENT
00812301020331	72" LEAD WIRES, REPLACEMENT
00812301020324	48" LEAD WIRES, REPLACEMENT
00812301020317	30" LEAD WIRES, REPLACEMENT
00812301020300	20" LEAD WIRES, REPLACEMENT
00812301020294	12" LEAD WIRES, REPLACEMENT
00812301020287	EXTREMITY BAND, REPLACEMENT
00812301020270	STIMULATOR HOLSTER, REPLACEMENT
00812301020263	BATTERY PACK CHARGER, REPLACEMENT
00812301020256	BATTERY PACK, REPLACEMENT
00812301020201	ELECTRODES 72R, SOFT TOUCH REPLACEMENT
00812301020195	ELECTRODE COVER PATCHES
00812301020188	ELECTRODES, LT-4500
00880304820852	ELECTRODES, 63B, SPINALPAK/ORTHOPAK
00880304820845	BELT EXTENSION, LARGE, SPINALPAK