FDA.reportPublic FDA data

Compressyn Staple

Primary DI
B470PEZ2425221
Brand
Compressyn Staple
Company
DALLEN MEDICAL, INC.
Model
PEZ-242522
Catalog number
PEZ-242522
Published
2016-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B470PEZ2425221PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical staple loading unit, non-cuttingA unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010690010
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B470PEZ1309071Compressyn StaplePEZ-130907PEZ-1309072016-11-02
B470PEZ1311101Compressyn StaplePEZ-131110PEZ-1311102016-11-02
B470PEZ1311151Compressyn StaplePEZ-131115PEZ-1311152016-11-02
B470PEZ1311171Compressyn StaplePEZ-131117PEZ-1311172016-11-02
B470PEZ1311191Compressyn StaplePEZ-131119PEZ-1311192016-11-02
B470PEZ1313101Compressyn StaplePEZ-131310PEZ-1313102016-11-02
B470PEZ1315121Compressyn StaplePEZ-131512PEZ-1315122016-11-02
B470PEZ1915121Compressyn StaplePEZ-191512PEZ-1915122016-11-02
B470PEZ1915181Compressyn StaplePEZ-191518PEZ-1915182016-11-02
B470PEZ1918181Compressyn StaplePEZ-191818PEZ-1918182016-11-02
B470PEZ1920201Compressyn StaplePEZ-192020PEZ-1920202016-11-02
B470PEZ2420201Compressyn StaplePEZ-242020PEZ-2420202016-11-02
B470PEZ2430301Compressyn StaplePEZ-243030PEZ-2430302016-11-02
00850815007004Compressyn StaplePEZ-243030PEZ-2430302016-07-11
00850815007011Compressyn StaplePEZ-242522PEZ-2425222016-07-11
00850815007028Compressyn StaplePEZ-242020PEZ-2420202016-07-11
00850815007035Compressyn StaplePEZ-192020PEZ-1920202016-07-11
00850815007042Compressyn StaplePEZ-191818PEZ-1918182016-07-11
00850815007059Compressyn StaplePEZ-191518PEZ-1915182016-07-11
00850815007066Compressyn StaplePEZ-191512PEZ-1915122016-07-11