FDA.reportPublic FDA data

Benacel Plus

Primary DI
D767B0224101
Brand
Benacel Plus
Company
UNICARE BIOMEDICAL INC.
Model
10x15mm
Catalog number
B02-2410
Device description
BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080532000BENACEL, MODELS C-001, C-002 AND C-005Unicare Biomedical, Inc.2008-11-12QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D767B0224101PrimaryHIBCC0
D767B0224100Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, bioabsorbableA bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment Humidity0 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-305-9600sales@unicarebiomedical.com

Regulatory Flags#

DUNS number
038023573
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D767C0701010CollaFlex15mm x 20mmC07-01012024-01-10
D767C0702010CollaFlex20mm x 30mmC07-02012024-01-10
D767C0703010CollaFlex30mm x 40mmC07-03012024-01-10
D767B0205101Benacel Plus5x5cmB02-05102024-07-12
D767B0210101Benacel Plus5x10cmB02-10102024-07-12
D767B0214101Benacel Plus5x20cmB02-14102024-07-12
D767B0222101Benacel Plus10x10cmB02-22102024-07-12
D767B0226101Benacel Plus10x20mmB02-26102024-07-12
D767C0609010Perforated Cytoflex Ti-enforced19x26mmC06-09012024-07-12
D767C0613010Perforated Cytoflex Ti-enforced20x25mmC06-13012024-07-12
D767C0617010Perforated Cytoflex Ti-enforced25x30mmC06-17012024-07-12
D767C0635010Perforated Cytoflex Ti-enforced25x36mmC06-35012024-07-12
D767C0639010Perforated Cytoflex Ti-enforced30x41mmC06-39012024-07-12
D767C0641010Perforated Cytoflex Ti-enforced32x40mmC06-41012024-07-12
D767C0801010Perforated Tefguard12x24mmC08-01012024-07-12
D767C0802010Perforated Tefguard25x30mmC08-02012024-07-12
D767C0501010Cytoflex Ti-enforced13x20mmC05-01012024-01-10
D767C0503010Cytoflex Ti-enforced12x24mmC05-03012024-01-10
D767C0505010Cytoflex Ti-enforced14x24mmC05-05012024-01-10
D767C0507010Cytoflex Ti-enforced18x29mmC05-07012024-01-10

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