FDA.reportPublic FDA data

COTTLE BONE MALLET

Primary DI
00192896047600
Brand
COTTLE BONE MALLET
Company
SONTEC INSTRUMENTS, INC.
Model
1100-461S
Catalog number
1100-461S
Device description
COTTLE BONE MALLET WITH STAINLESS STEEL HEAD ALUMINUM HANDLE
Published
2018-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXLMALLET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXLMalletGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896047600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896047600001928960476001928960476000192896047600

GMDN Terms#

Term, Definition table
TermDefinition
Surgical mallet headA device intended to replace the head of some types of surgical mallets and hammers. It is typically a solid cylinder of various diameters with flat ends; it is made of durable, non-splintering, synthetic polymer materials and is fixed (typically screwed using it's central screw thread) to the the distal end of the mallet. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length7.5Inch

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896094710INGE LAMINA SPREADER RETRACTOR417-056417-0562019-03-07
00192896123427Trocar20910-1120910-112026-06-02
00192896123434Flexible Trocar Sleeve15-16141-0315-16141-032026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817493028257Hive Standalone Cervical SystemNanohive Medical LLCHXL2026-05-08
00840311245635Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXL2026-03-18
00810158218871PRINCETONPrinceton Medical Group, Inc.HXL2026-02-16
B382SD9145561170Surgical DirectSurgical Direct, Inc.HXL2026-02-16
B382SD9141061010Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145561160Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD914556300Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145970180Surgical DirectSurgical Direct, Inc.HXL2026-02-09
03662663083683ActivLHighridge Medical, LLCHXL2026-02-03
00840180545829General InstrumentsALPHATEC SPINE, INC.HXL2026-01-29
00810158218482PRINCETONPrinceton Medical Group, Inc.HXL2026-01-15
00841731135322Redemption VILEX LLCHXL2026-01-12
03662663154543SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663154581SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663155601Zyston Interbody Spacer SystemHighridge Medical, LLCHXL2025-12-29
00840194418157PediflexORTHOPEDIATRICS CORP.HXL2025-12-11
03662663217002Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHXL2025-11-17
03662663267199Timberline Lateral Fusion SystemHighridge Medical, LLCHXL2025-11-16
00887868294976TM Ardis Interbody SystemHighridge Medical, LLCHXL2025-11-14
03662663129831Disc Preparation InstrumentsHighridge Medical, LLCHXL2025-11-14
03662663109239Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHXL2025-11-12
03662663109703Mergence-A Preparation InstrumentationHighridge Medical, LLCHXL2025-11-12
00810074308748250mm MalletOsteocentric Technologies, Inc.HXL2025-10-21
00810135963657ImpactNVISION BIOMEDICAL TECHNOLOGIES, INC.HXL2025-09-24
00810189110526MALLETOsteocentric Technologies, Inc.HXL2025-09-22
B382SD914554370Surgical DirectSurgical Direct, Inc.HXL2025-09-12
B382SD91455610310Surgical DirectSurgical Direct, Inc.HXL2025-09-12
00840314269812gSourceGSOURCE LLCHXL2025-08-29
00850078230041Disruptive MedTechMAHE MEDICAL USA LLCHXL2025-08-14
00757770423750Bausch + LombBausch & Lomb IncorporatedHXL2025-08-08