FDA.reportPublic FDA data

NA

Primary DI
07611819220966
Brand
NA
Company
Synthes GmbH
Model
399.092
Catalog number
399092
Device description
REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET
Published
2017-10-12
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
07611819220966Direct MarkingGS10
10886982202321PrimaryGS10
H6793990920SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819220966076118192209667611819220966
1088698220232110886982202321

GMDN Terms#

Term, Definition table
TermDefinition
Bone holding forcepsA manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. 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
486711679
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
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4250601180My MedicalMy Medical Store LLCHTD2026-05-04
G4250601350My MedicalMy Medical Store LLCHTD2026-05-04
G4250602970My MedicalMy Medical Store LLCHTD2026-05-04
G4250602980My MedicalMy Medical Store LLCHTD2026-05-04
G425310840NC0My MedicalMy Medical Store LLCHTD2026-05-04
G4254402140My MedicalMy Medical Store LLCHTD2026-05-04
G4254403120My MedicalMy Medical Store LLCHTD2026-05-04
G8142900SFPP3Garish ApparelsGARISH APPARELSHTD2026-04-28
09348811015402INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-21
09348811012678INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012722INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012913INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811013163INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811014603INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811129345INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
10649111493270Trinity Sterile, Inc.SKLAR CORPORATIONHTD2024-12-12
G586UR6201390Novo SurgicalNOVO SURGICAL, INC.HTD2024-07-23
10195327656256Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-07-10
10195327621100Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-02-05
G508RSCMD4700Raw Surgical CorporationRAW SURGICAL CORPORATIONHTD2023-11-19
G1413040800Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040820Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040840Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G25003003120Halsted Mosquito Forceps 12.5cm StraightN S SURGICAL COMPANYHTD2023-01-31
G25003004120Halsted Mosquito Forceps 12.5cm CurvedN S SURGICAL COMPANYHTD2023-01-31
G25003051180Standard Tube Forceps 18cmN S SURGICAL COMPANYHTD2023-01-30
G25003052180Foerster Sponge Forceps 18cm StraightN S SURGICAL COMPANYHTD2023-01-30
G25003001100Hartmann Mosquito Forcep 10cm StraightN S SURGICAL COMPANYHTD2023-01-28
G25003002100Hartmann Mosquito Forcep 10cm CurvedN S SURGICAL COMPANYHTD2023-01-28
G25003007120Micro Mosquito Forceps 12cm StraightN S SURGICAL COMPANYHTD2023-01-28