FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653160938
Brand
AESCULAP
Company
Aesculap AG
Model
FD568R
Catalog number
FD568R
Device description
"BIEMER Applying Forceps, straight, 5 3/4"", (145 mm), without ratchet, non-sterile, reusable"
Published
2020-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBTAPPLIER, HEMOSTATIC CLIP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBTApplier, Hemostatic ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653160938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653160938040386531609384038653160938

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. 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
03661522100882Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100899Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100905Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100929Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100936Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100912Applier, hemostatic clipPETERS SURGICALHBT2023-12-28
03661522039540Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039557Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039564Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039571Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039588Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039595Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039601Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039649Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039656Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039663Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039670Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039687Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039694Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039700Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039717Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039724Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039731Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039748Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039755Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039762Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039786Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039793Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039809Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039816Applier, hemostatic clipPETERS SURGICALHBT2023-06-08