FDA.reportPublic FDA data

NA

Primary DI
H9803989870
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
398.987
Catalog number
398987
Device description
BONE REDUCTION FORCEPS SMALL STRAIGHT
Published
2017-10-13
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
10887587041834PrimaryGS10
H9803989870SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758704183410887587041834

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
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424015MillenniumAvalign Technologies, Inc.HTD2026-08-27
00192896123632Adson Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-08-27
00190776419738MillenniumAvalign Technologies, Inc.HTD2026-08-25
00850088713596PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
00850088713619PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
04054462901821evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901852evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901869evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901876evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901883evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901890evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903405evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903450evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903467evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903504evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903573evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903597evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903603evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903634evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903641evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903658evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903665evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903672evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903740evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904129evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904143evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904235evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904273evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904310evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904358evonosevonos GmbH & Co. KGHTD2026-08-21