FDA.report

Lumbar Interbody Fusion System (OLLIF) 30mm Implant Caddy

Primary DI
00850014575571
Brand
Lumbar Interbody Fusion System (OLLIF) 30mm Implant Caddy
Company
ADVANCED RESEARCH MEDICAL LLC
Model
ARM 1900-600
Catalog number
ARM 1900-600
Device description
Lumbar Interbody Fusion System (OLLIF) 30mm Implant Caddy
Published
2020-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRPTray, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850014575571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014575571008500145755718500145755710850014575571

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
(612)440-1865info@advresmed.com

Regulatory Flags

DUNS number
117201206
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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