FDA.report

ZAVATION

Primary DI
00842166117716
Brand
ZAVATION
Company
ZAVATION LLC
Model
97-3520
Catalog number
NA
Device description
3.5mm x 20mm Polyaxial Shaft Screw
Published
2018-02-06
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

Related Records

Contact Domains

Product Codes

CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications

CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842166117716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166117716008421661177168421661177160842166117716

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 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

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