FDA.report

Blade, 38mm

Primary DI
00810097800243
Brand
Blade, 38mm
Company
SMV SCIENTIFIC LLC
Model
1252-5520-238
Catalog number
1252-5520-238
Device description
Blade, 38mm
Published
2022-02-17
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
true

Related Records

Contact Domains

Product Codes

CodeName
GESBlade, Scalpel
OURSacroiliac Joint Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810097800243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097800243008100978002438100978002430810097800243

GMDN Terms

TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Device Sizes

TypeValueUnit
Length38Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags

DUNS number
089645059
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
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

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008100743000324.0 x 18mm Screw Super Fastener, ST340-2018340-20182023-06-12
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008100743000634.0 x 24mm Screw Super Fastener, ST340-2024340-20242023-06-12
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