FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653176281
Brand
AESCULAP
Company
Aesculap AG
Model
OF254C
Catalog number
OF254C
Device description
HARTMANN Eustachian Catheter, diam. 5 mm
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
GBYCATHETER, EUSTACHIAN, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBYCatheter, Eustachian, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653176281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653176281040386531762814038653176281

GMDN Terms#

Term, Definition table
TermDefinition
Eustachian catheter, reusableA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown from an external bag through the device and into the middle ear. It is typically made of soft metals [e.g., silver (Ag) coated brass], and has a curved distal end with a slightly bulbous tip and a wider funnel-like proximal end with a finger ring to aid manipulation. 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
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24
04038653109999AESCULAPND118RND118R2020-05-08
04038653110018AESCULAPND121RND121R2020-05-08
04038653110056AESCULAPND125RND125R2020-05-06
04038653201303PROCARTFR600RFR600R2020-04-22
04038653088690AESCULAPFK352RFK352R2020-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653176243AESCULAPAesculap AGGBY2020-04-22
04038653176250AESCULAPAesculap AGGBY2020-04-22
04038653176267AESCULAPAesculap AGGBY2020-04-22
00888118057686CATHETERKLS-Martin L.P.GBY2018-09-26
00888118057693CATHETERKLS-Martin L.P.GBY2018-09-26
00888118057709CATHETERKLS-Martin L.P.GBY2018-09-26
10381780402916Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
10381780402923Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
M274X203531Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
M274X203571Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
10381780419327Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21
10381780419334Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21
H834192420Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21
H834192460Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21