FDA.report

AESCULAP

Primary DI
04038653335893
Brand
AESCULAP
Company
Aesculap AG
Model
PO757R
Catalog number
PO757R
Device description
BABCOCK ADTEC MONOPOLAR Organ Grasping Forceps, jaw inserts, straight, (420 mm), diam. 10 mm, serrated (cross), fenestrated, singleaction, reusable
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KNFCOAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653335893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653335893040386533358934038653335893

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
30817929020368Sonata® Dispersive ElectrodeGYNESONICS, INC.KNF2021-07-07
10817929020371Sonata® Radiofrequency Ablation HandpieceGYNESONICS, INC.KNF2021-07-07
10817929020173Sonata® RFA Handpiece Cable, ReusableGYNESONICS, INC.KNF2021-07-07
10817929020166Sonata® Procedure Kit GYNESONICS, INC.KNF2020-10-07
10817929020340Sonata System SoftwareGYNESONICS, INC.KNF2020-10-07
04042761086257OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
04038653285013ADTEC MONOPOLARAesculap AGKNF2020-07-07
04046955308781AESCULAPAesculap AGKNF2020-06-22
04046955334551AESCULAPAesculap AGKNF2020-06-22
04046955334575AESCULAPAesculap AGKNF2020-06-22
00810116021734Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021741Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021758Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
04038653183739AESCULAPAesculap AGKNF2020-04-23
04038653284825ADTEC MONOPOLARAesculap AGKNF2020-04-23
10817929020357Sonata® System SoftwareGYNESONICS, INC.KNF2020-02-21
10817929020005Sonata® Case Kit GYNESONICS, INC.KNF2019-05-10
10381780490357MicroFrance®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKNF2018-09-14
04048551102503n.a.Karl Storz GmbH & Co. KGKNF2018-07-21
04048551102527n.a.Karl Storz GmbH & Co. KGKNF2018-07-21
04048551094631BETTOCCHIKarl Storz GmbH & Co. KGKNF2017-10-20
04048551364864n.a.Karl Storz GmbH & Co. KGKNF2017-05-19
04048551347645n.a.Karl Storz GmbH & Co. KGKNF2016-12-22
04055207040133NARichard Wolf GmbHKNF2016-09-28
20653405035067CONMEDConmed CorporationKNF2016-09-24
20653405035098CONMEDConmed CorporationKNF2016-09-24
04046963682279AESCULAPAesculap AGKNF2016-09-24
04048551094396n.a.Karl Storz GmbH & Co. KGKNF2016-09-23
04048551393086n.a.Karl Storz GmbH & Co. KGKNF2016-09-23
04048551393567n.a.Karl Storz GmbH & Co. KGKNF2016-09-23