FDA.report

Scalpel Handle

Primary DI
08903317030802
Brand
Scalpel Handle
Company
OVATION INTERNATIONAL
Model
OI-2338S
Device description
TROUTMAN RAZOR BLADE HOLDER HOLDER 5.5 MM HANDLE, ANGLED
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
08903317030802PrimaryGS10

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

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08903317031397Opthalmic SpoonOI-3661S2022-02-04
08903317031403Opthalmic SpoonOI-3662S2022-02-04
08903317031410Opthalmic SpoonOI-3663S2022-02-04
08903317031427Opthalmic SpoonOI-3664S2022-02-04

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