FDA.reportPublic FDA data

O-ARM®

Primary DI
00885074546209
Brand
O-ARM®
Company
MEDTRONIC NAVIGATION, INC.
Model
9732722
Device description
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, x-ray, fluoroscopic, image-intensified
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050996000O-ARM IMAGING SYSTEMBreakaway Imaging, LLC2005-05-05OXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885074546203PackageGS120In Commercial Distribution
00885074546209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088507454620320885074546203
00885074546209008850745462098850745462090885074546209

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius37 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit99 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
803580559
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150054398StealthStation S897357622026-08-07
00199150054466N/A97367262026-08-08
00199150057078AXIS AP ROBOTIC TOOL CHANGER 973668197366812026-08-09
00199150067626KIT 9736691 SPINE REFERENCING97366912026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALL97364332026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUM97364652026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORT97364342026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUM97364672026-08-07
00763000381141N/A97314602026-08-08
00763000989927AXIS HYBRID REF FRAME 973651197365112026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 973651397365132026-08-07
00763000539238SteathStation97364262023-08-04
00763000539108SteathStation97364232022-02-07
00763000539177SteathStation97364262022-02-07
00763000914097Stealth AXiS97365032026-07-24
00763000914035Stealth AXiS97364812026-07-17
00763000914042Stealth AXiS97364822026-07-17
00763000914059Stealth AXiS97364832026-07-17
00763000914066Stealth AXiS97364842026-07-17
00763000914073Stealth AXiS97364852026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918100852AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918101774AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918103037AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918141121AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918145204AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918183800InvenioGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
30193489017742MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017759MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017766MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017773MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017780MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017797MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
00380657530021ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
00380659983313ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
00854810007199iXRSIcRco, Inc.JAA2026-07-22
B376KB100DAB0Drape KB100 SeriesKent Imaging IncPUI2026-07-21
10198956353954CARDINAL HEALTHCardinal Health 200, LLCPUI2026-07-20
20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
30193489028199MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
16931918102214AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918102948AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918107356AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
20193489108214MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
20888277636559MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)MolecuLight IncPUI2026-07-08
00628110259578MolecuLightDX DarkDrape Eco ClipMolecuLight IncPUI2026-07-08
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.JAA2026-07-08
06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., LtdPUI2026-07-08
00680211003276PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-07-06