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
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00763000994563Stealth AXiS EM Spine Retractors Kit SS97366992026-09-06
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00199150071593Stealth AXiS™ 3D-to-Fluoro Round Adapter Kit97367642026-08-22
00199150071616Stealth AXiS™ 3D-to-Fluoro Flat Adapter Kit97367662026-08-22
00763000989972Stealth AXiS™ 3D-to-Fluoro Flat C-arm Tracker97365192026-08-22
00763000989989Stealth AXiS™ 3D-to-Fluoro Round C-arm Tracker97365332026-08-22
00763000994587Stealth AXiS™ GEHC CRANIAL INTEGRATION KIT Stainless Steel97367002026-08-17
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00763000989958Stealth AXiS™ GEHC Craniotomy Transducer Tracker97365172026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification Device97365182026-08-15
00763000995195Stealth AXiS97366722026-08-14

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00680211003290PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-09-21
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10197344220090MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-09-18
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