FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653044412
Brand
AESCULAP
Company
Aesculap AG
Model
FF635R
Catalog number
FF635R
Device description
"FAHLBUSCH Pituitary Spoon, 10 1/4"", (260 mm), working length: 6 1/8"", (155 mm), diam. 2 mm, bayonet-shaped, malleable, sharp, roundhandle, non-sterile, reusable"
Published
2020-07-06
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
FHLSCOOP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHLScoopGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653044412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653044412040386530444124038653044412

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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
04049047109723GimmiGimmi GmbHFHL2025-05-27
04049047109747GimmiGimmi GmbHFHL2025-05-27
04049047109778GimmiGimmi GmbHFHL2025-05-27
04049047109785GimmiGimmi GmbHFHL2025-05-27
04049047109792GimmiGimmi GmbHFHL2025-05-27
04049047109808GimmiGimmi GmbHFHL2025-05-27
08403207009654Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009661Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009678Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009685Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
00887482173695Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174708Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174715Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174777Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174784Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174791Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174807Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00840343721763GEN2SURGIX MEDICAL LLCFHL2024-04-05
00810158210158PRINCETONPrinceton Medical Group, Inc.FHL2024-03-05
G586UR96223150Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225100Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225170Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225180Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225190Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96226120Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96226130Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96226140Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
00842331174582Novo Surgical Inc. NOVO SURGICAL, INC.FHL2022-11-14
00842331174599Novo Surgical Inc. NOVO SURGICAL, INC.FHL2022-11-14
00842331178900Novo Surgical Inc. NOVO SURGICAL, INC.FHL2022-11-14