FDA.report

AESCULAP

Primary DI
04038653171996
Brand
AESCULAP
Company
Aesculap AG
Model
GF320R
Catalog number
GF320R
Device description
Suction Irrigation Tube, (330 mm), diam. 5 mm, non-sterile, reusable, to be used with: PG052, PG072SU, PG073SU, SK330C
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653171996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653171996040386531719964038653171996

GMDN Terms

TermDefinition
Surgical irrigation/aspiration pumpAn electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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