FDA.reportPublic FDA data

Pacific Instruments

Primary DI
00850005084402
Brand
Pacific Instruments
Company
PACIFIC INSTRUMENTS, INC.
Model
PI-2477-04
Device description
Handle Extension Assembly
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005084402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005084402008500050844028500050844020850005084402

GMDN Terms#

Term, Definition table
TermDefinition
Wire cutterA heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810168190471NAPI-39182026-07-09
00810168190464NAPI-38742026-07-06
00810168190396NAPI-17942026-06-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489425LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
08809986489432LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
M9432002230000Liberty SISpinal Simplicity, LLCLXH2026-08-19
00198506093937ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00198506094194ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00810130207534MSIModern Surgical Instruments LLCLXH2026-08-18
00810198920345General InstrumentsTheraMicro, LLCLXH2026-08-18
00810198920352TeKForceTheraMicro, LLCLXH2026-08-18
00810198920376TeKForceTheraMicro, LLCLXH2026-08-18
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)Eca Medical InstrumentsLXH2026-08-18
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