The EASYGRIP FLO
EASYGRIP FLO-41 - ADS201897
Device Description
A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.
Environmental Conditions
- 25.00
- 2.00
Device Sizes
- Length: 41 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GCJ
Device Name: Laparoscope, General & Plastic Surgery
Device Class: 2
Physical State: N/A
Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 55413765586113
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05413765586118
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 05413765586118
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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