FDA.report

Innomed, Inc.

Primary DI
00840277114457
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
1644
Catalog number
1644
Device description
Swanson Elevator
Published
2021-03-15
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

Related Records

Product Codes

CodeName
HXDClamp

Product Code Classifications

CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840277114457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277114457008402771144578402771144570840277114457

GMDN Terms

TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
878427491
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
00840277133427Innomed, Inc.7325-007325-002026-03-20
00840277133403Innomed, Inc.4576-02-564576-02-562026-03-11
00840277133410Innomed, Inc.4576-564576-562026-03-11
00840277133359Innomed, Inc.4535-304535-302026-02-26
00840277133366Innomed, Inc.4535-904535-902026-02-26
00840277133373Innomed, Inc.3440-L3440-L2026-02-26
00840277133380Innomed, Inc.3440-R3440-R2026-02-26
00840277133182Innomed, Inc.2725-EU2725-EU2026-02-06
00840277133199Innomed, Inc.4090-EU4090-EU2026-02-06
00840277133205Innomed, Inc.4095-EU4095-EU2026-02-06
00840277133212Innomed, Inc.4105-EU4105-EU2026-02-06
00840277133229Innomed, Inc.4165-00-EU4165-00-EU2026-02-06
00840277133236Innomed, Inc.8840-EU8840-EU2026-02-06
00840277133243Innomed, Inc.117211722026-02-06
00840277133250Innomed, Inc.117311732026-02-06
00840277133267Innomed, Inc.T1018-KTT1018-KT2026-02-06
00840277133274Innomed, Inc.T1019-KTT1019-KT2026-02-06
00840277133281Innomed, Inc.T1020-KTT1020-KT2026-02-06
00840277133298Innomed, Inc.T1021-KTT1021-KT2026-02-06
00840277133304Innomed, Inc.T1022-KTT1022-KT2026-02-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00192896122680Schroeder Vulsellum Bone ClampSONTEC INSTRUMENTS, INC.HXD2026-03-10
B356JD259280American MedicalsAmerican MedicalsHXD2026-03-09
00190776416706MillenniumAvalign Technologies, Inc.HXD2026-02-20
00190776415877MillenniumAvalign Technologies, Inc.HXD2026-02-04
00810123209781Adler Instrument CompanyAdler, Inc.HXD2026-01-28
00810123209798Adler Instrument CompanyAdler, Inc.HXD2026-01-28
00841013124532American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124549American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124556American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124563American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00888480670728Timberline Lateral Fusion SystemHighridge Medical, LLCHXD2025-12-18
05060624126697CS Fixed Blade ClampCARE SURGICAL LIMITEDHXD2025-12-17
03662663196741Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
03662663196758Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
03662663196796Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
09421038410479Enztec Inverted Premium Patella ClampENZTEC LIMITEDHXD2025-12-11
09421038410486Enztec Premium Cement Clamp - RotatingENZTEC LIMITEDHXD2025-12-11
00840277133113Innomed, Inc.INNOMED, INC.HXD2025-12-02
00840338603685Tornier HRS MaxTORNIER, INC.HXD2025-11-18
00840338603944Tornier HRS MaxTORNIER, INC.HXD2025-11-18
03662663137027Polaris 4.75 Deformity SystemHighridge Medical, LLCHXD2025-11-14
00840277133038Innomed, Inc.INNOMED, INC.HXD2025-11-12
00885556768471EVOSSmith & Nephew, Inc.HXD2025-11-12
00885556908846EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911112EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911129EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911136EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911143EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911150EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911167EVOSSmith & Nephew, Inc.HXD2025-11-11