FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653209408
Brand
AESCULAP
Company
Aesculap AG
Model
ER871R
Catalog number
ER871R
Device description
LEECH-WILKINSON Uterine Irrigation Cannula, 10 1/2", (265 mm), diam. 10 mm - 25 mm, small, non-sterile, reusable
Published
2020-06-17
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
FGYCANNULA, INJECTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGYCannula, InjectionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653209408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653209408040386532094084038653209408

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
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
00810192690718CerosRhino Medical Supply IncFGY2025-11-18
00850041572994CerosRhino Medical Supply IncFGY2024-03-19
20866497000305ClearVu 2.7 BluntCannuflow, Inc.FGY2024-01-16
20866497000312ClearVu 2.7 SharpCannuflow, Inc.FGY2024-01-16
20866497000329EntreVuCannuflow, Inc.FGY2024-01-16
20866497000336ExtravaStopperCannuflow, Inc.FGY2024-01-16
20866497000343TwoVuCannuflow, Inc.FGY2024-01-16
20866497000350TwoVuCannuflow, Inc.FGY2024-01-16
20866497000367TwoVuCannuflow, Inc.FGY2024-01-16
20866497000374TwoVuCannuflow, Inc.FGY2024-01-16
00850023741875CER-SUB-1590RANFAC CORP.FGY2023-12-13
00614950029976ACEACE SURGICAL SUPPLY CO., INC.FGY2023-12-05
00614950029983ACEACE SURGICAL SUPPLY CO., INC.FGY2023-12-05
00190776308025MillenniumAVALIGN TECHNOLOGIES, INC.FGY2023-06-23
06936841208098IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812197IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812203IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812210IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812227IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812234IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162816843IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162816850IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162816867IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162816874IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162816881IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
00887482076873Symmetry SurgicalSYMMETRY SURGICAL INC.FGY2022-12-08
00887482076897Symmetry SurgicalSYMMETRY SURGICAL INC.FGY2022-12-08
00858690006815RIN-11-11RANFAC CORP.FGY2022-11-09
00858690006822RIN-15-60RANFAC CORP.FGY2022-11-09
00887482079980Symmetry Surgical®SYMMETRY SURGICAL INC.FGY2022-09-21