FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653155231
Brand
AESCULAP
Company
Aesculap AG
Model
FA006R
Catalog number
FA006R
Device description
"LABORDE Tracheal Dilator, 5"", (125 mm), non-sterile, reusable"
Published
2020-04-22
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
04038653155231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653155231040386531552314038653155231

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
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

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