FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00763000353469
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX1119033
Device description
COBB EX1119033 SUCKER 28MM
Published
2022-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000353469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000353469007630003534697630003534690763000353469

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169839397INFINITY™ Occipitocervical Upper Thoracic System36070052018-06-10
00199150082780Medtronic Reusable InstrumentsX02260232026-07-04
00199150082797Medtronic Reusable InstrumentsX02260242026-07-04
00199150082803Medtronic Reusable InstrumentsX02260252026-07-04
00199150082810Medtronic Reusable InstrumentsX02260262026-07-04
00199150082827Medtronic Reusable InstrumentsX02260272026-07-04
00199150082834Medtronic Reusable InstrumentsX02260282026-07-04
00199150082841Medtronic Reusable InstrumentsX02260292026-07-04
00199150082858Medtronic Reusable InstrumentsX02260302026-07-04
00199150082865Medtronic Reusable InstrumentsX02260312026-07-04
00199150082872Medtronic Reusable InstrumentsX02260322026-07-04
00199150082889Medtronic Reusable InstrumentsX02260332026-07-04
00199150082896Medtronic Reusable InstrumentsX02260342026-07-04
00763000873714MSB SHILLA Growth Guidance System76750252026-07-04
00763000875176MSB SHILLA Growth Guidance System76755352026-07-04
00643169101296MSB VERTEX® Reconstruction SystemG77538052026-06-27
00643169465879MSB CD HORIZON Spinal SystemX10131802026-06-28
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy System43612052026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy System4361203002026-06-26
00643169190542CLYDESDALE PTC™ Spinal System49868402016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09