FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653042470
Brand
AESCULAP
Company
Aesculap AG
Model
ET140R
Catalog number
ET140R
Device description
"BRAUN-STADLER Episiotomy Scissors, angled to side, 5 3/4"", (145 mm), serrated (one blade), non-sterile, reusable"
Published
2020-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDKSCISSORS, EPISIOTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDKScissors, EpisiotomyObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653042470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653042470040386530424704038653042470

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

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
Premarket exempt
true
Lot or batch
true
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
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047003205GimmiGimmi GmbHHDK2025-04-22
04049047003212GimmiGimmi GmbHHDK2025-04-22
04049047003229GimmiGimmi GmbHHDK2025-04-22
04049047679844GimmiGimmi GmbHHDK2025-04-22
04049047679851GimmiGimmi GmbHHDK2025-04-22
00840183526207BR Surgical, LLCBR Surgical, LLCHDK2024-03-28
G586OB6441260Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
G586OB96442290Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
00190776050337AvalignAvalign Technologies, Inc.HDK2023-09-28
00190776250621AvalignAvalign Technologies, Inc.HDK2023-09-28
07898506853847QuinelatoSchobell Industrial LtdaHDK2023-07-11
00190776250669AvalignAvalign Technologies, Inc.HDK2023-06-23
00840183513542BR Surgical, LLCBR Surgical, LLCHDK2023-04-14
07898506852406QuinelatoSchobell Industrial LtdaHDK2023-01-11
14026704792105PILLINGTELEFLEX INCORPORATEDHDK2022-12-08
54026704792103PILLINGTELEFLEX INCORPORATEDHDK2022-12-08
00842331161261Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00842331167171Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00842331171772Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00887482024171Symmetry BraunASPEN SURGICAL PRODUCTS, INC.HDK2022-09-21
00887482039465Symmetry Braun-StadlerASPEN SURGICAL PRODUCTS, INC.HDK2022-09-21
00887482039472Symmetry WaldmannASPEN SURGICAL PRODUCTS, INC.HDK2022-09-21
00887482018644Symmetry Bookwalter®ASPEN SURGICAL PRODUCTS, INC.HDK2022-08-23
00190660157180Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
00190660157197Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
04046826070595MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046826070618MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046955086597AESCULAPAESCULAP, INC.HDK2020-05-06
04038653042487AESCULAPAesculap AGHDK2020-04-20
10381780500612Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDK2018-09-18