FDA.report

inViZia™

Primary DI
00889024325531
Brand
inViZia™
Company
ZIMMER SPINE, INC.
Model
07.01610.008
Catalog number
07.01610.008
Published
2016-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024325531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024325531008890243255318890243255310889024325531

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)774-6368zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags

DUNS number
787663400
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00889024333499Minit®300-4018300-40182015-09-24
00889024334977Sequoia®3306-55503306-55502015-09-24
00889024335004Sequoia®3306-65303306-65302015-09-24
00889024335059Sequoia®3306-65553306-65552015-09-24
00889024335134Sequoia®3306-75603306-75602015-09-24
00889024335165Sequoia®3306-85403306-85402015-09-24
00889024335486Sequoia®3361-0553361-0552016-06-23
00889024331419InFix® Anterior Lumbar System1850-51121850-51122016-06-23
00889024331426InFix® Anterior Lumbar System1850-51141850-51142016-06-23
00889024331433InFix® Anterior Lumbar System1850-53081850-53082016-06-23
00889024331440InFix® Anterior Lumbar System1850-53141850-53142016-06-23
00889024331457InFix® Anterior Lumbar System1850-55081850-55082016-06-23
00889024331464InFix® Anterior Lumbar System1850-55121850-55122016-06-23
00889024402577InFix® Anterior Lumbar System1850-51001850-51002016-06-23
00889024402584InFix® Anterior Lumbar System1850-51081850-51082016-06-23
00889024402591InFix® Anterior Lumbar System1850-51101850-51102016-06-23
00889024402607InFix® Anterior Lumbar System1850-53101850-53102016-06-23
00889024402614InFix® Anterior Lumbar System1850-53121850-53122016-06-23
00889024402621InFix® Anterior Lumbar System1850-55101850-55102016-06-23
00889024402638InFix® Anterior Lumbar System1850-55141850-55142016-06-23

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