FDA.reportPublic FDA data

NA

Primary DI
00810168190310
Brand
NA
Company
PACIFIC INSTRUMENTS, INC.
Model
PI-3904
Device description
Long Instrument Discectomy Set
Published
2026-05-11
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
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
00810168190310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810168190310008101681903108101681903100810168190310

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
621872006
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
00810168190495NAPI-36102026-08-21
00810168190471NAPI-39182026-07-09
00810168190464NAPI-38742026-07-06
00810168190396NAPI-17942026-06-26
00810168190457NAPI-34152026-05-26
00810168190327NAPI-39052026-05-11
00810168190334NAPI-39062026-05-11
00810168190341NAPI-39072026-05-11
00810168190358NAPI-39082026-05-11
00810168190365NAPI-39092026-05-11
00810168190372NAPI-39102026-05-11
00810168190389NAPI-39112026-05-11
00810168190402NAPI-39132026-05-11
00810168190419NAPI-39142026-05-11
00810168190426NAPI-36152026-05-11
00810168190433NAPI-39162026-05-11
00810168190440NAPI-39172026-05-11
00810168190303NAPI-12192026-03-16
00810168190297NAPI-38752026-03-03
00810168190167NAPI-38422026-01-29

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
00810161901104EARP, IMPLANT LID 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