FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653166336
Brand
AESCULAP
Company
Aesculap AG
Model
FK348R
Catalog number
FK348R
Device description
"Raspatory, curved, 11 1/2"", (290 mm), sharp, peek handle, width: 20 mm, non-sterile, reusable"
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
HTRRASP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653166336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653166336040386531663364038653166336

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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
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
00199150082780Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082797Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082803Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082810Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082827Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082834Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082841Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082858Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082865Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082872Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082889Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082896Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
08800322752043AnyPlus®GS Medical Co., Ltd.HTR2026-01-28
08800104077364AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.HTR2025-03-17
08800104077371AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.HTR2025-03-17
08800104077388AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.HTR2025-03-17
08800104077395AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.HTR2025-03-17
08800104099717QUASAR-IFGS Medical Co., Ltd.HTR2023-02-20
08806395408917PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408924PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408931PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408948PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408955PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408962PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408979PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408986PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408993PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395409006PulsarGS Medical Co., Ltd.HTR2022-11-01
10381780503231Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2020-10-01
00841732124684GENERIC Surgical InstrumentsCTL Medical CorporationHTR2019-10-18