FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963938017
Brand
AESCULAP
Company
Aesculap AG
Model
GB695R
Catalog number
GB695R
Device description
CLEANING DEVICE F/MICRO-LINE HANDPIECES
Published
2020-08-24
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
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963938017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963938017040469639380174046963938017

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, reusableA device intended to be used to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, telescopic tube, magnetic mat), may be attached to a surgical drape, and may be used for subsequent sterilization of the instrument(s); it is not a numbered tray and is not intended for counting of sharps. 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

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