FDA.reportPublic FDA data

ORTHOPEDIC GOUGE

Primary DI
00192896092846
Brand
ORTHOPEDIC GOUGE
Company
SONTEC INSTRUMENTS, INC.
Model
330-627
Catalog number
330-627
Device description
ORTHOPEDIC GOUGE CURVED TIP
Published
2019-01-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896092846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896092846001928960928461928960928460192896092846

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gougeA heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

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00192896123441Barraquer Anis Needle Holder15-3810Q15-3810Q2026-06-02
00192896105553Rochester Carmalt Forceps1100-1541100-1542020-11-16
00192896105591Bone Tamp335-400335-4002020-11-18
00192896105607Bone Tamp335-404335-4042020-11-18
00192896102637Carmalt Forceps1100-152L1100-152L2020-06-15
00192896101524BONE TAMP1103-197A1103-197A2020-05-11
00192896099715WILDE ETHMOID RONGEUR468-622468-6222018-09-20
00192896094109ROCHESTER CARMALT FORCEPS1100-153Q1100-153Q2019-03-07
00192896094475ROCHESTER CARMALT FORCEPS1100-152Q1100-152Q2019-03-07
00192896094567ROCHESTER CARMALT FORCEPS1100-150Q1100-150Q2019-03-07
00192896094758BLAKESLEY ETHMOID RONGEUR468-686468-6862019-03-07
00192896095861ETHMOID PEDIATRIC RONGEUR468-590Q468-590Q2019-03-25
00192896041028ETHMOID PEDIATRIC RONGEUR468-580468-5802018-09-10
00192896041035ETHMOID PEDIATRIC RONGEUR468-585468-5852018-09-11
00192896041042ETHMOID PEDIATRIC RONGEUR468-590468-5902018-09-10
00192896041059WILDE ETHMOID RONGEUR468-600468-6002018-09-10
00192896041066WILDE ETHMOID RONGEUR468-606468-6062018-09-11

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