FDA.reportPublic FDA data

NA

Primary DI
07611819283015
Brand
NA
Company
Synthes GmbH
Model
398.754
Catalog number
398754
Device description
PERCUTANEOUS ARM 255MM
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
07611819283015Direct MarkingGS10
10886982201584PrimaryGS10
H6793987540SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819283015076118192830157611819283015
1088698220158410886982201584

GMDN Terms#

Term, Definition table
TermDefinition
Temporal bone holderA surgical device used to hold a piece of bone in a clamped position outside of the surgical field while the surgeon and/or other helping assistants work on it. It is typically used to reshape bone or for creating grafting material. This device will typically have a sturdy foot, a clamp to hold the bone, and an integral dish-like bowl to catch the bone fragments/cuttings. 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
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

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