Cranial LOOP XL

GUDID 48437006085067

Cranial bur hole cover

Primary Device ID	48437006085067
NIH Device Record Key	c6170e9d-e7d1-46df-92e5-fe3c3ea80919
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cranial LOOP XL
Version Model Number	FC050200
Company DUNS	465890437
Company Name	NEOS SURGERY SL
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	false
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	18437006085066 [Primary]
GS1	28437006085063 [Package] Contains: 18437006085066 Package: [64 Units] In Commercial Distribution
GS1	38437006085060 [Package] Contains: 18437006085066 Package: [6 Units] In Commercial Distribution
GS1	48437006085067 [Package] Contains: 38437006085060 Package: [10 Units] In Commercial Distribution

GXR	Cover, Burr Hole

Steralize Prior To Use	false
Device Is Sterile	true

08437006085182 - Depth Gauge	2024-09-12 DEPTH GAUGE
08437006085212 - Retractor	2024-09-12
08437006085434 - Cutter	2024-09-12
28437006085452 - STERN FIX	2024-09-12 STERN FIX Sternal Stabilization System, Size 2
28437006085469 - STERN FIX	2024-09-12 STERN FIX Sternal Stabilization System- size 3
08437006085472 - STERN FIX	2024-09-12 STERN FIX Sternal Stabilization System-Size 4
28437006085483 - STERN FIX	2024-09-12 STERN FIX Sternal Stabilization System- Size 5
08437006085496 - Forceps	2024-09-12