FDA.reportPublic FDA data

NA

Primary DI
07611819325876
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
03.809.940
Catalog number
03809940
Device description
IMPLANT REMOVER
Published
2016-12-31
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
07611819325876Direct MarkingGS10
10705034726823PrimaryGS10
H981038099400SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819325876076118193258767611819325876
1070503472682310705034726823

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H981PDL432FNAPDL432PDL4322017-02-20
H981PDL434HNAPDL434PDL4342017-02-20
07611819995796NA03.820.144038201442016-12-31
07611819943490NAE5115-7E511572017-02-20
H679E51157P09NAE5115-7PE51157P2016-12-31
10886982293060NA04.045.260040452602025-01-31
10886982293237NA04.045.230040452302025-01-31
10886982293244NA04.045.232040452322025-01-31
10886982293251NA04.045.234040452342025-01-31
10886982293268NA04.045.236040452362025-01-31
10886982293275NA04.045.238040452382025-01-31
10886982293282NA04.045.240040452402025-01-31
10886982293299NA04.045.242040452422025-01-31
10886982293305NA04.045.244040452442025-01-31
10886982293312NA04.045.246040452462025-01-31
10886982293329NA04.045.248040452482025-01-31
10886982293336NA04.045.250040452502025-01-31
10886982293343NA04.045.252040452522025-01-31
10886982293350NA04.045.254040452542025-01-31
10886982293367NA04.045.256040452562025-01-31

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