FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653042449
Brand
AESCULAP
Company
Aesculap AG
Model
ER876
Catalog number
ER876
Device description
Uterine Irrigation Cannula with two interchangeable cones, 13 3/4", (350 mm), non-sterile, reusable
Published
2020-06-17
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
LKFCannula, manipulator/injector, uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653042449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653042449040386530424494038653042449

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilator, reusableA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. 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
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
20859500005008FemVueFEMASYS INC.LKF2026-01-06
30859500005005FemVueFEMASYS INC.LKF2026-01-06
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
10860010540937Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
00840306835360Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835377Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835384Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835391Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835407Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835544Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835896Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835902Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836022Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836046Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836053Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00198506074264ELMED INCORPORATEDELMED INCORPORATEDLKF2025-01-15
00198506017858ELMED INCORPORATEDELMED INCORPORATEDLKF2025-01-10
04719894432977Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432984Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432991Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894433004Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
00198506017827ELMED INCORPORATEDELMED INCORPORATEDLKF2024-11-14
00859500005097FemChec FEMASYS INC.LKF2024-09-16
00840306830044Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830051Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830068Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830075Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06