FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653050956
Brand
AESCULAP
Company
Aesculap AG
Model
OF259R
Catalog number
OF259R
Device description
LATHBURY-FARRELL APPLICTRTRISER110MM
Published
2020-04-20
Public version status
New
Distribution status
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
KCJAPPLICATOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653050956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653050956040386530509564038653050956

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, reusableA hand-held manual device in the form of a slender handle made of metal intended to hold an absorbent material such as a cotton pledget at its distal end for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is typically used in a healthcare setting. 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
00757770410972Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420179Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420766Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770427383Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00850027492698NavägeRhinosystems, Inc.KCJ2024-11-15
00887482037898Symmetry Surgical®SYMMETRY SURGICAL INC.KCJ2024-08-15
00840183517489BR Surgical, LLCBR Surgical, LLCKCJ2024-05-29
04055207009734NARichard Wolf GmbHKCJ2024-05-21
00850022483073Saline Noze MistDr. Noze BestKCJ2024-02-05
G586E1032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E1035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032250Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032270Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032290Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032770Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032790Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035460Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
00842331192524Novo Surgical Inc. NOVO SURGICAL, INC.KCJ2023-12-07
25060259070420Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
45060259070486Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070857DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
55060259070988DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
55060259070995DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
15060259073127DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259073131DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
00705928002043NeilMed Sinus RinseNEILMED PHARMACEUTICALS, INC.KCJ2023-03-02
00705928003002NeilMed Sinus RinseNEILMED PHARMACEUTICALS, INC.KCJ2023-03-02
00705928003101Sinus Rinse KitNEILMED PHARMACEUTICALS, INC.KCJ2023-03-02