FDA.report

ENNOVATE

Primary DI
08033860028671
Brand
ENNOVATE
Company
Aesculap AG
Model
SZ364SU
Catalog number
SZ364SU
Device description
ENNOVATE Aspiration Needle short, (150 mm), (120 mm), diam. 3,50 mm, trocar tip, plastic handles, stainless steel, sterile, disposable, package of 5 pieces
Published
2020-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033860028671PrimaryGS10

GMDN Terms

TermDefinition
Bone access channel kitA collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
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04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

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