FDA.report

GRUBER CARTILAGE CUTTING BLOCK

Primary DI
00192896032019
Brand
GRUBER CARTILAGE CUTTING BLOCK
Company
SONTEC INSTRUMENTS, INC.
Model
350-845
Catalog number
350-845
Device description
GRUBER CARTILAGE CUTTING BLOCK WITH GRID
Published
2018-09-10
Public version status
Update
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
HWNINSTRUMENT, COMPRESSION
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896032019PrimaryGS10

GMDN Terms

TermDefinition
Surgical cutting/shaping boardA non-sterile, stiff, plastic device designed to be used as a surface for trimming/contouring objects or tissues [e.g., porous polyethylene (PE) orthopaedic implants, corneal transplants] in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Height2Millimeter
Height10Millimeter
Length70Millimeter
Length100Millimeter
Width40Millimeter
Width60Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
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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