FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653042661
Brand
AESCULAP
Company
Aesculap AG
Model
FA005R
Catalog number
FA005R
Device description
"TROUSSEAU Tracheal Dilator, 4 3/4"", (120 mm), 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
KCFDILATOR, ESOPHAGEAL, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCFDilator, Esophageal, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653042661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653042661040386530426614038653042661

GMDN Terms#

Term, Definition table
TermDefinition
Tracheal surgery dilator, reusableA hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs and sizes, e.g., a slender hollow or solid body made of metal, plastic or other suitable material in a cylindrical form, or a scissors-like instrument that when activated by closing the two ringed-handles, two or three blunted curved prongs expand in opposite directions. 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
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
08906039312096OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312102OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312119OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312126OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312133OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312140OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314366OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314342OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314328OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314304OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314281OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314267OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
G422DL0030MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MMBIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
G422DL1010DILATOR CERVICAL SET OF 6BIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
G422DL3000HANK DILATOR DOUBLE ENDED 7/8 FRBIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
G422DL3010HANK DILATOR SET OF 6 (Z304)BIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
00827002352674HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352681HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352698HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352704HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352711HerculesCOOK INCORPORATEDKCF2022-12-20
14063107100281Montgomery® Esophageal TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100298Montgomery® Esophageal TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100304Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100311Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100328Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100335Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100342Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100359Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100366Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29