FDA.reportPublic FDA data

NA

Primary DI
H980398980
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
398.98
Catalog number
39898
Device description
REDUCTION FORCEPS W/POINTS 180MM RATCHET
Published
2018-08-29
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
10887587041803PrimaryGS10
H980398980SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758704180310887587041803

GMDN Terms#

Term, Definition table
TermDefinition
Bone holding forcepsA surgical instrument designed to grasp and hold a bone during a 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
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
10886982027795NA02.007.000S02007000S2015-09-14
10886982066763NA03.007.020030070202016-12-31
10886982160898NA237.043S237043S2015-09-14
10886982160904NA237.044S237044S2015-09-14
10886982160928NA237.054S237054S2015-09-14
10886982160935NA237.063S237063S2015-09-14
10886982160942NA237.064S237064S2015-09-14
10886982160959NA237.083S237083S2015-09-14
10886982160966NA237.084S237084S2015-09-14
10886982160973NA237.085S237085S2015-09-14
10886982160980NA237.086S237086S2015-09-14
10886982161000NA237.104S237104S2015-09-14
10886982161017NA237.105S237105S2015-09-14
10886982161024NA237.106S237106S2015-09-14
10886982161031NA237.123S237123S2015-09-14
10886982161048NA237.124S237124S2015-09-14
10886982161055NA237.125S237125S2015-09-14
10886982162038LCP238.7002387002015-09-14
10886982162052LCP238.7012387012015-09-14
10886982162076LCP238.7022387022015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806373899997BENCOXCorentec Co., LtdHTD2026-06-09
04052536162000neon3Ulrich GmbH & Co. KGHTD2026-06-08
04052536162017neon3Ulrich GmbH & Co. KGHTD2026-06-08
00810189451001Surgical DesignSurgical Design, Inc.HTD2026-06-06
G8142900SF3Garish ApparelsGARISH APPARELSHTD2026-06-06
G8142900SFFPPP3Garish ApparelsGARISH APPARELSHTD2026-06-06
G8142905SF3Garish ApparelsGARISH APPARELSHTD2026-06-06
04046964683039AESCULAPAESCULAP, INC.HTD2026-06-05
00766588283463Cohesive Wrap - 2"x 5 ydsCertified Safety Manufacturing, Inc.HTD2026-06-04
10766588283460Cohesive Wrap - 2"x 5 yds - UDI/10Certified Safety Manufacturing, Inc.HTD2026-06-04
04052536161959neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161966neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161973neon3Ulrich GmbH & Co. KGHTD2026-05-28
D9282000201SUL0SMITH SAGGITAL SPLITTER-MODW.H. Holden, Inc.HTD2026-05-27
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
04052536052912uCentumUlrich GmbH & Co. KGHTD2025-08-04