FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653164134
Brand
AESCULAP
Company
Aesculap AG
Model
FF624R
Catalog number
FF624R
Device description
"HARDY Implant Fork, 9 5/8"", (245 mm), working length: , 4 3/4"", (120 mm), bayonet-shaped, round handle, non-sterile, reusable"
Published
2020-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXEFORK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXEForkOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653164134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653164134040386531641344038653164134

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889797111317Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXE2025-08-26
00191083033204Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2024-12-18
00191083033211Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2024-12-12
00191083033198Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2024-03-31
00842962170779HNM MedicalHNM STAINLESS, LLC.HXE2024-03-07
00190776337773MillenniumAvalign Technologies, Inc.HXE2023-06-23
00191083033181Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2023-03-31
04047844111765COSYSIGNUS Medizintechnik GmbHHXE2023-03-15
00191083033174Cross-Fuse® II PEEK IBF SystemPioneer Surgical Technology, Inc.HXE2022-03-31
B922F00400270ACURA Stabilization System - Rod Lever/ Reduction ForkINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHXE2022-03-21
00840192715241FAICO CMF SystemFAICO MEDICAL LLCHXE2021-04-20
00840192715548FAICO CMF SystemFAICO MEDICAL LLCHXE2021-04-20
08800037544964ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HXE2020-11-14
04046963780128ACTIV CAesculap AGHXE2020-04-24
04046963783143ACTIV CAesculap AGHXE2020-04-24
04038653403943NOVOCARTAesculap AGHXE2020-04-23
08800037523969ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HXE2020-01-12
08800015999939ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HXE2019-07-29
00889024577527ExtremitiesZimmer, Inc.HXE2019-07-01
00840019925853PSS SystemPRECISION SPINE, INC.HXE2019-03-27
07640139349149OTELO INSTRUMENTATIONSpineArt SAHXE2019-02-01
00888118120144FORKKLS-Martin L.P.HXE2018-11-22
00846468011208Cross-Fuse® II PEEK VBR/IBF SystemPioneer Surgical Technology, Inc.HXE2018-10-06
00888118064400FORKKLS-Martin L.P.HXE2018-09-26
24026704291865KMEDICTELEFLEX INCORPORATEDHXE2018-09-15
08800015951982Optima™ Spinal SystemCG MedTech Co.,Ltd.HXE2017-11-02
08800015959438OPTIMA™ ZS Spinal SystemCG MedTech Co.,Ltd.HXE2017-10-31
08800015959414OPTIMA™ ZS Spinal SystemCG MedTech Co.,Ltd.HXE2017-10-31
M697C06700430Certex Spinal Fixation SystemXtant Medical Holdings, Inc.HXE2017-04-01
10889981080419MalibuSeaspine Orthopedics CorporationHXE2016-05-02