FDA.reportPublic FDA data

Scalpel Handle

Primary DI
08903317031038
Brand
Scalpel Handle
Company
OVATION INTERNATIONAL
Model
OI-2318S
Device description
BLADE HANDLE FLAT
Published
2022-01-21
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
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08903317031038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903317031038089033170310388903317031038

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
879324241
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08903317013706Ophthalmic KnifeOVS612252022-01-07
08903317013713Ophthalmic KnifeOVS61302022-01-07
08903317013720Ophthalmic KnifeOVS61452022-01-07
08903317013737Ophthalmic KnifeOVS62102022-01-07
08903317013744Ophthalmic KnifeOVS62122022-01-07
08903317013751Ophthalmic KnifeOVS62142022-01-07
08903317013768Ophthalmic KnifeOVS62162022-01-07
08903317013775Ophthalmic KnifeOVS621242022-01-07
08903317013782Ophthalmic KnifeOVS62182022-01-07
08903317013799Ophthalmic KnifeOVS62202022-01-07
08903317013805Ophthalmic KnifeOVS62222022-01-07
08903317013812Ophthalmic KnifeOVS62242022-01-07
08903317013829Ophthalmic KnifeOVS62252022-01-07
08903317013836Ophthalmic KnifeOVS62262022-01-07
08903317013843Ophthalmic KnifeOVS622652022-01-07
08903317013850Ophthalmic KnifeOVS62272022-01-07
08903317013867Ophthalmic KnifeOVS622752022-01-07
08903317013874Ophthalmic KnifeOVS62282022-01-07
08903317013881Ophthalmic KnifeOVS622852022-01-07
08903317013898Ophthalmic KnifeOVS62302022-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267742Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-25
D955BLAHST1Paul BandittTerlain Enterprises, Inc.GDZ2026-09-25
00724995267728Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-24
00190776429072MillenniumAvalign Technologies, Inc.GDZ2026-09-04
00724995314682V. MuellerSteris CorporationGDZ2026-08-21
00724995314699V. MuellerSteris CorporationGDZ2026-08-21
00724995314705V. MuellerSteris CorporationGDZ2026-08-21
00724995314712V. MuellerSteris CorporationGDZ2026-08-21
00724995314729V. MuellerSteris CorporationGDZ2026-08-21
00724995317362V. MuellerSteris CorporationGDZ2026-08-21
00724995317379V. MuellerSteris CorporationGDZ2026-08-21
00724995320492V. MuellerSteris CorporationGDZ2026-08-21
00724995320508V. MuellerSteris CorporationGDZ2026-08-21
00724995320515V. MuellerSteris CorporationGDZ2026-08-21
00724995320522V. MuellerSteris CorporationGDZ2026-08-21
00724995320539V. MuellerSteris CorporationGDZ2026-08-21
00724995343446V. MuellerSteris CorporationGDZ2026-08-21
04054462913466evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913473evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913480evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913527evonosevonos GmbH & Co. KGGDZ2026-08-19
00190776422837MillenniumAvalign Technologies, Inc.GDZ2026-08-03
07613327651188VersiQuadSTRYKER CORPORATIONGDZ2026-07-22
00190776396800MillenniumAvalign Technologies, Inc.GDZ2026-07-14
00850083275563Intrace USAPILOTIS TECH LLCGDZ2026-07-03
00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255726Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255788Surgical DesignSurgical Design, Inc.GDZ2026-06-26