FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963344337
Brand
AESCULAP
Company
Aesculap AG
Model
MF253R
Catalog number
MF253R
Device description
"Curette, forward straight, 8 1/2"", (215 mm), working length: 3 1/8"", (80 mm), bayonet-shaped, sharp, Fig. 000, non-sterile, reusable"
Published
2020-04-23
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
FZSCURETTE, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963344337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963344337040469633443374046963344337

GMDN Terms#

Term, Definition table
TermDefinition
Spinal curetteA hand-held, sterile surgical instrument used to scrape and score the cancellous vertebral bone of the spine, typically during a percutanous, minimally-invasive procedure. It consists of a long, thin, metal shaft that terminates distally in a mushroom-like cutting head that can be set at alternative angles (up to ninety degrees). The device enables a smooth scoring action for the creation of grooves or channels, and is typically used as an adjunct device in the treatment of vertebral compression fractures (VCFs) during kyphoplasty. This is a single-use 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
B382SD9147092060Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092120Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092130Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092140Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096450Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096460Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096470Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096510Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096520Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096530Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096540Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096550Surgical DirectSurgical Direct, Inc.FZS2026-07-09
07640139342119ROMEO 2 INSTRUMENTATIONSpineArt SAFZS2025-11-10
04046963939588NOVOCARTAesculap AGFZS2020-04-24
04046963315511NOVOCARTAesculap AGFZS2020-04-23
04046963315528NOVOCARTAesculap AGFZS2020-04-23
10649111094002SklarSKLAR CORPORATIONFZS2019-08-26
10649111094088SklarSKLAR CORPORATIONFZS2019-08-26
10649111217210SklarSKLAR CORPORATIONFZS2019-03-15
10649111217494SklarSKLAR CORPORATIONFZS2019-03-15
10649111217586SklarSKLAR CORPORATIONFZS2019-03-15
10649111217838SklarSKLAR CORPORATIONFZS2019-03-15
10649111017711SklarSKLAR CORPORATIONFZS2019-03-13
10649111017858SklarSKLAR CORPORATIONFZS2019-03-13
10649111018084SklarSKLAR CORPORATIONFZS2019-03-13
10649111018282SklarSKLAR CORPORATIONFZS2019-03-13
10649111018619SklarSKLAR CORPORATIONFZS2019-03-13
10649111161612SklarSKLAR CORPORATIONFZS2019-03-13
10649111161964SklarSKLAR CORPORATIONFZS2019-03-13
10649111162060SklarSKLAR CORPORATIONFZS2019-03-13