FDA.reportPublic FDA data

Pacific Instruments

Primary DI
00850005084112
Brand
Pacific Instruments
Company
PACIFIC INSTRUMENTS, INC.
Model
PI-2993
Device description
Sterilization Tray for Hybrid Rod Cutter
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005084112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005084112008500050841128500050841120850005084112

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
Premarket exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810168190457NAPI-34152026-05-26
00810168190310NAPI-39042026-05-11
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
00850005084334NAPI-34342023-09-01
00850005084693NAPI-25822024-03-28
00850005084082NAPI-33782024-03-18

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Primary DI, Brand, Company table
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10198956446366CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956471351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956485761CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956492684CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956493513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956495425CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956498983CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956500389CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
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07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
07630894802683APTUSMedartis AGFSM2023-02-24
07630894802973APTUSMedartis AGFSM2023-02-24
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