FDA.report

Intra-Lock

Primary DI
D742BCS0
Brand
Intra-Lock
Company
INTRA-LOCK INTERNATIONAL, INC.
Model
BCS
Catalog number
BCS
Device description
Blood Collection Kit
Published
2019-06-19
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D742BCS0PrimaryHIBCC0

GMDN Terms

TermDefinition
Haematological concentrate systemAn assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, the concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process.

Sterilization Methods

Method

Regulatory Flags

DUNS number
131500998
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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D742S37080BlossomS3708S37082017-02-07
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D742SCT40100BlossomSCT4010SCT40102017-02-07
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D742SCT40130BlossomSCT4013SCT40132017-02-07
D742SCT40150BlossomSCT4015SCT40152017-02-07

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