FDA.reportPublic FDA data

NA

Primary DI
00810168190143
Brand
NA
Company
PACIFIC INSTRUMENTS, INC.
Model
PI-3452
Device description
Nonparallel Compressor for up to 6.0mm Rod
Published
2025-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWNInstrument, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810168190143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810168190143008101681901438101681901430810168190143

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant handling forcepsA hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. It is made of metal materials and may have one of various designs (e.g., tweezers-, scissors-, alligator-like) whereby the blades are designed to be opened/closed to handle a variety of implantable devices (e.g., orthopaedic joint prosthesis, breast implant, surgical mesh). This is a reusable device intended to be sterilized prior to use.

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
00810168190495NAPI-36102026-08-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982357335VOLTSynthes GmbHHWN2026-09-25
10886982357342VOLTSynthes GmbHHWN2026-09-25
10886982357359VOLTSynthes GmbHHWN2026-09-25
10886982357366VOLTSynthes GmbHHWN2026-09-25
10886982357373VOLTSynthes GmbHHWN2026-09-25
10886982357380VOLTSynthes GmbHHWN2026-09-25
10886982357397VOLTSynthes GmbHHWN2026-09-25
10886982357403VOLTSynthes GmbHHWN2026-09-25
10886982357410VOLTSynthes GmbHHWN2026-09-25
10886982357427VOLTSynthes GmbHHWN2026-09-25
10886982357434VOLTSynthes GmbHHWN2026-09-25
10886982357441VOLTSynthes GmbHHWN2026-09-25
10886982357458VOLTSynthes GmbHHWN2026-09-25
10886982357465VOLTSynthes GmbHHWN2026-09-25
10886982357472VOLTSynthes GmbHHWN2026-09-25
10886982357489VOLTSynthes GmbHHWN2026-09-25
10886982357823VOLTSynthes GmbHHWN2026-09-25
10886982357830VOLTSynthes GmbHHWN2026-09-25
00850083430009SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430047SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430078SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430092SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00840311251148Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251155Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251162Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251179Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251377Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWN2026-03-30