FDA.reportPublic FDA data

EARP, IMPLANT LID 18X35

Primary DI
00810161901104
Brand
EARP, IMPLANT LID 18X35
Company
RETROPSOAS TECHNOLOGIES, LLC
Model
EARP-IC_1835-02
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810161901104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810161901104008101619011048101619011040810161901104

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression instrument set, reusableA collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119266920
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
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
00810161900305EARP, TRIAL 22X35X12 6°EARP-T-2235-06122026-10-16
00810161900312EARP, TRIAL 22X35X14 6°EARP-T-2235-06142026-10-16
00810161900329EARP, TRIAL 22X35X12 12°EARP-T-2235-12122026-10-16
00810161900336EARP, TRIAL 22X35X14 12°EARP-T-2235-12142026-10-16
00810161900381EARP, 14X25X08 0°EARP1425-00082026-10-16
00810161900398EARP, 14X25X10 6°EARP1425-06102026-10-16
00810161900404EARP, 14X25X12 6°EARP1425-06122026-10-16
00810161900411EARP, 14X25X12 12°EARP1425-12122026-10-16
00810161900428EARP, 14X30X08 0°EARP1430-00082026-10-16
00810161900435EARP, 14X30X10 6°EARP1430-06102026-10-16
00810161900442EARP, 14X30X12 6°EARP1430-06122026-10-16
00810161900459EARP, 14X30X12 12°EARP1430-12122026-10-16
00810161900466EARP, 14X35X08 0°EARP1435-00082026-10-16
00810161900473EARP, 14X35X10 6°EARP1435-06102026-10-16
00810161900480EARP, 14X35X12 6°EARP1435-06122026-10-16
00810161900497EARP, 14X35X12 12°EARP1435-12122026-10-16
00810161900503EARP, 14X40X10 6°EARP1440-06102026-10-16
00810161900510EARP, 14X40X12 6°EARP1440-06122026-10-16
00810161900527EARP, 14X40X12 12°EARP1440-12122026-10-16
00810161900534EARP, 18X30X08 0°EARP1830-00082026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956558793CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956572447CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956578470CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956589575CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956599901CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956604216CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611450CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611863CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956617384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956619241CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
00810161900992EARP, IMPLANT CADDY 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901005EARP, IMPLANT LID 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901012EARP, IMPLANT CADDY 14X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901029EARP, IMPLANT LID 14X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901036EARP, IMPLANT CADDY 14X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901043EARP, IMPLANT LID 14X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901050EARP, IMPLANT CADDY 14X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901067EARP, IMPLANT LID 14X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901074EARP, IMPLANT CADDY 18X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901081EARP, IMPLANT LID 18X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901098EARP, IMPLANT CADDY 18X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901111EARP, IMPLANT CADDY 18X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901128EARP, IMPLANT LID 18X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901135EARP, IMPLANT CADDY 18X45RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901142EARP, IMPLANT CADDY 18X50RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901159EARP, IMPLANT CADDY 22X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901166EARP, IMPLANT LID 22X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901173EARP, IMPLANT CADDY 22X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901180EARP, IMPLANT LID 22X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901197EARP, IMPLANT CADDY 22X45RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16