FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653260287
Brand
AESCULAP
Company
Aesculap AG
Model
PO628R
Catalog number
PO628R
Device description
ADTEC MONOPOLAR TC monopolar Needleholder jaw inserts, straight, (310 mm), diam. 5 mm, single action, non-sterile, reusable
Published
2016-05-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNFCOAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653260287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653260287040386532602874038653260287

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
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
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