FDA.reportPublic FDA data

ZAVATION

Primary DI
00842166117815
Brand
ZAVATION
Company
ZAVATION LLC
Model
97-3540
Catalog number
NA
Device description
3.5mm x 40mm Polyaxial Shaft Screw
Published
2018-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166117815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166117815008421661178158421661178150842166117815

GMDN Terms#

Term, Definition table
TermDefinition
Microplate seal roller IVDA manually-operated device intended to firmly apply a seal to a microplate. It consists of a cylindrical-shaped roller attached to a handle and is typically made of metal and plastic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
601-919-1119info@zavation.com

Regulatory Flags#

DUNS number
069472800
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
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
00197157071400ZAVATION ROD BENDER989-1065-R 2025-09-15
00197157071417ZAVATION ROD BENDER989-1065-L 2025-09-15
00197157071455ZAVATION CADDY1010-9002-12025-09-15
00197157071462ZAVATION CADDY1010-9002-22025-09-15
00197157071479ZAVATION CADDY1010-9002-32025-09-15
00197157071486ZAVATION CADDY1010-9002-42025-09-15
00197157071493ZAVATION CADDY1010-9002-52025-09-15
00197157071509ZAVATION CADDY LID1010-9002-62025-09-15
00197157071516ZAVATION CADDY LID1010-9002-72025-09-15
00197157071523ZAVATION CADDY 1010-9002-82025-09-15
00197157071530ZAVATION CADDY LID1010-9002-92025-09-15
00197157071547ZAVATION CADDY LID1010-9002-102025-09-15
00197157071585ZAVATION RODR5509-0352025-09-15
00197157071592ZAVATION RODR5509-0402025-09-15
00197157071608ZAVATION RODR5509-0452025-09-15
00197157071615ZAVATION RODR5509-0502025-09-15
00197157071622ZAVATION RODR5509-0552025-09-15
00197157071639ZAVATION RODR5509-0602025-09-15
00197157071646ZAVATION RODR5509-0652025-09-15
00197157071653ZAVATION RODR5509-0702025-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536216710neon3Ulrich GmbH & Co. KGKWP2026-05-26
00763000817305VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
00763000817312VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
03662663086233LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091046LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091084LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091091LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097345LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097352LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097369LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097376LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097383LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097390LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097406LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097413LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097420LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097437LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097444LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097451LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097468LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097475LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097482LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097499LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097505LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097512LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097529LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097536LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097543LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097550LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097567LineSiderHighridge Medical, LLCKWP2025-10-03