FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653166541
Brand
AESCULAP
Company
Aesculap AG
Model
FK510R
Catalog number
FK510R
Device description
"Bone File, 11 3/4"" (295 mm), serrated (cross), width: 20 mm"
Published
2020-04-22
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
HTPFILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTPFileOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653166541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653166541040386531665414038653166541

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
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
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10810128463581Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2026-05-13
06974940306642endophixSuzhou Endophix Co., Ltd.HTP2025-12-12
10818674026618Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
10818674026625Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
04047844052501INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844067390INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844099742INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844101117INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844101155INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844126998INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
00840286841955Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853965Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853972Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286841009TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-21
00840286855990TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856003TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856010TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856027TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856034TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840124518742FuzeFix MiniFUSION ORTHOPEDICS, LLCHTP2025-05-13
04047844059852INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-05-09
04046826034801MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHTP2025-05-07
04047844058442INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-05-05
04047844058558RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058565RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058572RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058589RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058596RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058602RABEASIGNUS Medizintechnik GmbHHTP2025-03-12