FDA.reportPublic FDA data

Biodesign

Primary DI
10827002476544
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G47654
Catalog number
SLH-4-PR1
Device description
Biodesign Peyronie's Repair Graft
Published
2015-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062320000SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100Cook Biotech, Inc.2006-10-02FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002476544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700247654410827002476544

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in clean, dry location at room temperature
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
945385862
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10827002311418BiodesignG31141C-IHM-10X152015-11-03
10827002314518BiodesignG31451C-IHM-6X13-P2015-11-03
10827002314525BiodesignG31452C-IHM-8X15-P2015-11-03
00827002231191OASISG231198213-0000-132019-03-11
00827002352421OASISG352428213-0000-162019-03-11
00827002352438OASISG352438213-0000-172019-03-12
00827002352445OASISG352448213-0000-182019-03-11
00827002352452OASISG352458213-0000-192019-03-11
00827002466227OASISG466228213-1000-332019-03-11
00827002466234OASISG466238213-2000-332019-04-17
00827002466265OASISG466268213-1000-372019-03-11
00827002466272OASISG466278213-2000-372019-04-17
00827002564633OASISG564638213-0000-092019-03-11
00827002564657OASISG564658213-0000-112019-03-11
00827002576018OASISG576018213-3000-092019-03-11
00827002576025OASISG576028213-3000-112019-03-11
00827002576032OASISG576038213-3000-132019-03-11
00827002576049OASISG576048213-3000-162019-03-11
00827002576056OASISG576058213-3000-172019-03-11
00827002576063OASISG576068213-3000-182019-03-11

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