FDA.reportPublic FDA data

ACCULAN

Primary DI
04038653444847
Brand
ACCULAN
Company
Aesculap AG
Model
GA679
Catalog number
GA679
Device description
Acculan 3Ti battery removal device
Published
2020-04-23
Public version status
New
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
MOQBATTERY, REPLACEMENT, RECHARGEABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOQBattery, Replacement, RechargeableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653444847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653444847040386534448474038653444847

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical power tool system, rechargeable battery-poweredAn assembly of devices designed to resect bones and tough tissues (e.g., cartilage, ligaments) during a surgical procedure; it is not dedicated to a specific clinical application. It includes a rechargeable battery pack/control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, burs, saw blades, screwdriver bits, and guide wires); it is not intended to be connected to mains power.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
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
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
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819595011175Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015029Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015661Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015685Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015692Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015876Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015906Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015944Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016040Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016118Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016125Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016149Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016163Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016750Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016781Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016828Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016880Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016897Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016910Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016934Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016941Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016958Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016965Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016972Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017092Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017108Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017115Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017122Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017139Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017146Artisan PowerArtisan Power LLCMOQ2026-02-10