FDA.reportPublic FDA data

Pediflex

Primary DI
00840194418157
Brand
Pediflex
Company
ORTHOPEDIATRICS CORP.
Model
01-1001-0008
Catalog number
01-1001-0008
Device description
PediFlex Forked Mallet
Published
2025-12-11
Public version status
New
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
00840194418157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194418157008401944181578401944181570840194418157

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379xxx@xxx.com

Regulatory Flags#

DUNS number
796416191
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
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00841132199244OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6000-S00-1200-6000-S2026-05-13
00841132199251OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6001-S00-1200-6001-S2026-05-13
00841132199268OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6002-S00-1200-6002-S2026-05-13
00841132199275OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6003-S00-1200-6003-S2026-05-13
00841132199282OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6004-S00-1200-6004-S2026-05-13
00841132199299OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6005-S00-1200-6005-S2026-05-13
00841132199305OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6006-S00-1200-6006-S2026-05-13
00841132199312OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6014-S00-1200-6014-S2026-05-13
00841132199329OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6015-S00-1200-6015-S2026-05-13

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
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
00757770428953Bausch + LombBausch & Lomb IncorporatedHXL2025-08-08