FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653339785
Brand
AESCULAP
Company
Aesculap AG
Model
GC615R
Catalog number
GC615R
Device description
SAW BLADE 23/0.25/0.35MM STERILE
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HABSAW, POWERED, AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HABSaw, Powered, And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653089451PrimaryGS10
04038653339785Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653089451040386530894514038653089451
04038653339785040386533397854038653339785

GMDN Terms#

Term, Definition table
TermDefinition
Reciprocating surgical saw blade, reusableA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315018218
Device count
10
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08809260472037TRAUSSaeshin Precision Co., Ltd.HAB2026-05-07
08809260471924TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471931TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471948TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471955TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471962TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471979TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471986TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471993TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472006TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472013TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472020TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473041TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473058TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473065TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473072TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473089TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473096TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473102TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
30653405990738Hall® Titan™Conmed CorporationHAB2025-12-29
30653405990745Hall® Titan™Conmed CorporationHAB2025-12-29
10653405005513HALLConmed CorporationHAB2023-12-04
10653405005711HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005728HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005735HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005742HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005759HALL MICROFREEConmed CorporationHAB2023-10-12
00885556826676First Choice DRUJ SystemSmith & Nephew, Inc.HAB2023-08-02
00885556856840Ascension MCP Joint ReplacementSmith & Nephew, Inc.HAB2023-08-02
00885556857663NuGrip CMCSmith & Nephew, Inc.HAB2023-08-02