FDA.report

Scalpel Handle

Primary DI
08903317030635
Brand
Scalpel Handle
Company
OVATION INTERNATIONAL
Model
OI-2305S
Device description
CASTROVIEJO RAZOR BLADE HOLDER 8MM HANDLE, STRAIGHT
Published
2022-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GDZHandle, Scalpel

Product Code Classifications

CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08903317030635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08903317030635089033170306358903317030635

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
879324241
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
08903317017452Opthalmic SpoonOI-3152T2022-02-04
08903317017469Opthalmic SpoonOI-3153T2022-02-04
08903317018138Opthalmic SpoonOI-3658T2022-02-04
08903317018145Opthalmic SpoonOI-3659T2022-02-04
08903317018152Opthalmic SpoonOI-3660T2022-02-04
08903317018169Opthalmic SpoonOI-3661T2022-02-04
08903317018176Opthalmic SpoonOI-3662T2022-02-04
08903317018183Opthalmic SpoonOI-3663T2022-02-04
08903317018190Opthalmic SpoonOI-3664T2022-02-04
08903317018206Opthalmic SpoonOI-3665T2022-02-04
08903317031076Opthalmic SpoonOI-3151S2022-02-04
08903317031083Opthalmic SpoonOI-3152S2022-02-04
08903317031090Opthalmic SpoonOI-3153S2022-02-04
08903317031366Opthalmic SpoonOI-3658S2022-02-04
08903317031373Opthalmic SpoonOI-3659S2022-02-04
08903317031380Opthalmic SpoonOI-3660S2022-02-04
08903317031397Opthalmic SpoonOI-3661S2022-02-04
08903317031403Opthalmic SpoonOI-3662S2022-02-04
08903317031410Opthalmic SpoonOI-3663S2022-02-04
08903317031427Opthalmic SpoonOI-3664S2022-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776418038MillenniumAvalign Technologies, Inc.GDZ2026-03-23
16937372521523comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521530comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521547comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521554comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521561comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521578comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
B382SD914010350Surgical DirectSurgical Direct, Inc.GDZ2026-02-25
B382SD4811280Surgical DirectSurgical Direct, Inc.GDZ2026-02-16
00190776416157MillenniumAvalign Technologies, Inc.GDZ2026-02-06
00840124525320FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
00840124525337FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
09348811000019INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000095INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000132INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000149INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000170INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000187INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000194INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000200INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000217INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000224INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014146INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014856INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014863INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811151452INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
00840124525245FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-01-22
00841013120480Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-06
00841013124327American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02
00841013124334American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02