FDA.reportPublic FDA data

SABER-C BASE WITH INSERT TRAY

Primary DI
00810017913497
Brand
SABER-C BASE WITH INSERT TRAY
Company
ELEVATION SPINE, INC.
Model
CI-TRAY2-SABERC
Catalog number
CI-TRAY2-SABERC
Device description
SABER-C BASE WITH INSERT TRAY
Published
2024-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810017913497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017913497008100179134978100179134970810017913497

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
085718404
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.CBT-2567-PCBT-2567-P2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.CP-4726CP-47262026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.CP-4727CP-47272026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.CP-4728CP-47282026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialCI-DRIVER3M-5-7CI-DRIVER3M-5-72026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralCI-DRIVER3L-5-7CI-DRIVER3L-5-72026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialCI-DRIVER3M-8-9CI-DRIVER3M-8-92026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralCI-DRIVER3L-8-9CI-DRIVER3L-8-92026-06-05
00810017913657Saber-C Body (PT), 12x15x6 6 deg.CBT-2566-PCBT-2566-P2026-06-01
0081001791165312 (w) X 15 (d) Saber-C Cervical PlateCP-2568CP-25682019-12-20
0081001791166012 (w) X 15 (d) Saber-C Cervical PlateCP-2569CP-25692019-12-20
0081001791167712 (w) X 15 (d) Saber-C Cervical PlateCP-2561CP-25612019-12-20
0081001791168412 (w) X 15 (d) Saber-C Cervical PlateCP-2595CP-25952019-12-20
0081001791169112 (w) X 15 (d) Saber-C Cervical PlateCP-2596CP-25962019-12-20
0081001791170712 (w) X 15 (d) Saber-C Cervical PlateCP-2597CP-25972019-12-20
0081001791171412 (w) X 15 (d) Saber-C Cervical PlateCP-2598CP-25982019-12-20
0081001791172112 (w) X 15 (d) Saber-C Cervical PlateCP-2599CP-25992019-12-20
0081001791173812 (w) X 15 (d) Saber-C Cervical PlateCP-2591CP-25912019-12-20
0081001791174514 (w) X 15 (d) Saber-C Cervical PlateCP-4505CP-45052019-12-20
0081001791175214 (w) X 15 (d) Saber-C Cervical PlateCP-4506CP-45062019-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091278ELMED INCORPORATEDELMED INCORPORATEDLRP2026-06-09
04052536163434neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164585neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164592neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164608neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536177516neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536221202uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221219uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221233uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536162116neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162130neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162147neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162154neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162215neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176724neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176748neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176755neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176762neon3Ulrich GmbH & Co. KGLRP2026-06-08
10198956433755CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956461109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956476950CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956479999CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956485112CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956487475CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490635CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956494817CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956501362CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956505841CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956506381CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08