FDA.reportPublic FDA data

General Instrument

Primary DI
00841132124505
Brand
General Instrument
Company
ORTHOPEDIATRICS CORP.
Model
01-0907-0013
Catalog number
01-0907-0013
Device description
Ball Reduction Forceps - Small
Published
2016-09-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132124505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132124505008411321245058411321245050841132124505

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796416191
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
false

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
00840194498975Response 5.5/6.001-1300-935001-1300-93502026-03-03
00840194498982Response 5.5/6.001-1300-936001-1300-93602026-03-03
00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
00840536800251Response 5.5/6.001-1300-913601-1300-91362026-03-03
00840194499194Contracture ManagementNS-6000-3001NS-6000-30012026-03-02
00840194499200Contracture ManagementNS-6000-3002NS-6000-30022026-03-02
00840194499217Contracture ManagementNS-6000-3003NS-6000-30032026-03-02
00840194499224Contracture ManagementNS-6000-3004NS-6000-30042026-03-02
00840194499231Contracture ManagementNS-6000-3005NS-6000-30052026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00766588420103Forceps - MagnifierCertified Safety Manufacturing, Inc.HTD2026-05-26
10766588420100Forceps - Magnifier UDI/10Certified Safety Manufacturing, Inc.HTD2026-05-26
00810143907537SURGIPROSSurgipros, LLCHTD2026-05-23
00190776417994MillenniumAvalign Technologies, Inc.HTD2026-03-23
24026704941494PILLINGTELEFLEX INCORPORATEDHTD2026-03-23
24026704941500PILLINGTELEFLEX INCORPORATEDHTD2026-03-23
00192896122857Diamond Head Grasping ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-19
00810158219267PRINCETONPrinceton Medical Group, Inc.HTD2026-03-12
00810158219274PRINCETONPrinceton Medical Group, Inc.HTD2026-03-12
00810158219045PRINCETONPrinceton Medical Group, Inc.HTD2026-03-11
00192896122741Micro Alligator ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
00192896122758Brophy Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
B382S1350010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382020Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382030Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382040Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382050Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382060Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382100Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382110Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382120Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S9057001000Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD901132120Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD901186250Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018372010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018372040Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382020Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382030Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD90118621C0Surgical DirectSurgical Direct, Inc.HTD2026-02-26