FDA.reportPublic FDA data

BAGUERA® C

Primary DI
07640221370877
Brand
BAGUERA® C
Company
SpineArt SA
Model
CDP-BX 10 03-N
Device description
TRIAL RACK
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QLQManual Instruments Designed For Use With Total Disc Replacement Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLQManual Instruments Designed For Use With Total Disc Replacement DevicesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640221370877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640221370877076402213708777640221370877

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
483016148
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640139342287Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 08-SDYN-BS 22 08-S2018-03-12
07640139342294Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 10-SDYN-BS 22 10-S2018-03-12
07640139342300Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 12-SDYN-BS 22 12-S2018-03-12
07640139342317Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 14-SDYN-BS 22 14-S2018-03-12
07640139343819Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 16-SDYN-BS 22 16-S2018-03-12
07640151087500BGran® Synthetic Osteoconductive ScaffoldBGS-005BGS-0052017-09-18
07640151087517BGran® Synthetic Osteoconductive ScaffoldBGS-010BGS-0102017-09-18
07640151087524BGran® Synthetic Osteoconductive ScaffoldBGS-015BGS-0152017-09-18
07640151087531BGran® Synthetic Osteoconductive ScaffoldBGS-030BGS-0302017-09-18
07640151087654BGran® Synthetic Osteoconductive ScaffoldBGF-001BGF-0012017-09-18
07640151087661BGran® Synthetic Osteoconductive ScaffoldBGF-005BGF-0052017-09-18
07640151087678BGran® Synthetic Osteoconductive ScaffoldBGF-010BGF-0102017-09-18
07640151087685BGran® Synthetic Osteoconductive ScaffoldBGL-015BGL-0152017-09-18
07640151087692BGran® Synthetic Osteoconductive ScaffoldBGL-030BGL-0302017-09-18
07640139343185BAGUERA C INSTRUMENTATIONCDP-IN 30 01-N2026-08-27
07640221370884TRYPTIK® TiTRY-BX 40 01-N2026-08-27
07640178972452ROMEO posterior osteosynthesis systemNAV-IN 01 00-NNAV-IN 01 00-N2019-01-31
07640221370891BAGUERA® CBAG-CT 13 05-S2026-08-21
07640221370907BAGUERA® CBAG-CT 13 06-S2026-08-21
07640221370914BAGUERA® CBAG-CT 13 07-S2026-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843193115300Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115317Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115324Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115331Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115348Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115355Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115362Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115379Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115386Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
07640139343079BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370525BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370532BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370549BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370556BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370563BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370570BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370587BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370594BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370600BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370617BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370624BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370631BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370648BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370655BAGUERA® CSpineArt SAQLQ2026-08-19
00843193111838Prodisc L InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112323Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112330Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112347Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112354Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112361Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08