FDA.report

CollaMend FM Implant

Primary DI
00801741010590
Brand
CollaMend FM Implant
Company
Davol Inc.
Model
1175115
Catalog number
1175115
Device description
CollaMend FM Implant Ellipse
Published
2015-06-02
Public version status
Update
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

Contact Domains

Product Codes

CodeName
FTMMesh, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741010590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741010590008017410105908017410105900801741010590

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length10Inch
Width8Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)562-0027medical.services@crbard.com
+1(800)562-0027medical.services@bd.com

Regulatory Flags

DUNS number
001191048
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
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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