FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964072628
Brand
AESCULAP
Company
Aesculap AG
Model
FK653R
Catalog number
FK653R
Device description
"Bone Curette, slightly curved, 7 1/2"", (190 mm), width: 3 mm, non-sterile, reusable"
Published
2020-04-24
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
KBJCURETTE, ADENOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBJCurette, AdenoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964072628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964072628040469640726284046964072628

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
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
05060411984127Beckmann Adenoid Curette, 10mm Curette Edge, 220mmDTR MEDICAL LIMITEDKBJ2026-06-10
05060411984141Beckmann Adenoid Curette, 13mm Curette Edge, 220mmDTR MEDICAL LIMITEDKBJ2026-06-10
05060411984165Beckmann Adenoid Curette, 15mm Curette Edge, 220mmDTR MEDICAL LIMITEDKBJ2026-06-10
05060411984189Beckmann Adenoid Curette, 17mm Curette Edge, 220mmDTR MEDICAL LIMITEDKBJ2026-06-10
00194613048723MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048730MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
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00194613048792MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
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00194613048846MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
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04049047340003GimmiGimmi GmbHKBJ2025-05-22
04049047340010GimmiGimmi GmbHKBJ2025-05-22
04049047340027GimmiGimmi GmbHKBJ2025-05-22
04049047340034GimmiGimmi GmbHKBJ2025-05-22
04049047371595GimmiGimmi GmbHKBJ2025-05-22
04049047371601GimmiGimmi GmbHKBJ2025-05-22
04049047385509GimmiGimmi GmbHKBJ2025-05-22
04049047385516GimmiGimmi GmbHKBJ2025-05-22
04049047387497GimmiGimmi GmbHKBJ2025-05-22
00194613048709MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048716MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048761MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21