FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653152964
Brand
AESCULAP
Company
Aesculap AG
Model
EJ801R
Catalog number
EJ801R
Device description
TROCAR BODY 7MM
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
DXCCLAMP, VASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653152964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653152964040386531529644038653152964

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
false
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
20197344138897NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
00192896122697Cooley Vascular ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122710Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122727Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00884450846032Safeguard Radial™Merit Medical Systems, Inc.DXC2026-02-20
00840479401027enableCV IntraClude™ Intra-Aortic Occlusion DeviceENABLECV INC.DXC2026-02-06
18022057015881DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015891DeTACH Aortic Cross Clamp Head- MediumCORCYM SRLDXC2026-02-03
18022057015904DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
08022057015914DeTACH Aortic Cross Clamp Delivery SystemCORCYM SRLDXC2026-02-03
08022057015921DeTACH Aortic Cross Clamp Quick Release DeviceCORCYM SRLDXC2026-02-03
08022057015945DeTACH Aortic Cross Clamp Delivery DeviceCORCYM SRLDXC2026-02-03
00810123209507Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209514Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209521Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209538Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209545Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209552Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209583Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209590Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209606Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209613Adler Instrument CompanyAdler, Inc.DXC2025-08-19
54026704930840PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930857PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930864PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930871PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930888PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930895PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
00192896121638Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17
00192896121645Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17