FDA.reportPublic FDA data

FlexiGRAFT®

Primary DI
00889858612401
Brand
FlexiGRAFT®
Company
LIFENET HEALTH
Model
FCON40150
Catalog number
FCON
Device description
Connect Pre-Sutured Tendon (4x150 MM)
Published
2018-08-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889858612401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889858612401008898586124018898586124010889858612401

GMDN Terms#

Term, Definition table
TermDefinition
Tendon graftA sterile tendon tissue, which may include a bone block, intended for transplantation that is harvested from a human donor. The tissue is intended to be used to replace or strengthen damaged tendon in any part of the human body. It may include non-tissue components (e.g. suture) to facilitate its implantation or function. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-847-7831xx@xx.xx

Regulatory Flags#

DUNS number
121828156
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889858640800PliaFX FloBL-2200-00BL-2200-002025-01-01
00889858640817PliaFX FloBL-2200-01BL-2200-012025-01-01
00889858640824PliaFX FloBL-2200-02BL-2200-022025-01-01
00889858640831PliaFX FloBL-2200-05BL-2200-052025-01-01
00889858640848PliaFX FloBL-2200-10BL-2200-102025-01-01
00889858640855PliaFX FloBL-2225-00BL-2225-002025-01-01
00889858640862PliaFX FloBL-2225-01BL-2225-012025-01-01
00889858640879PliaFX FloBL-2225-02BL-2225-022025-01-01
00889858640886PliaFX FloBL-2225-05BL-2225-052025-01-01
00889858640893PliaFX FloBL-2225-10BL-2225-102025-01-01
00889858640244ViviGen MIS Delivery SystemBL-1925-001BL-1925-0012024-02-15
00889858638562FlexiGRAFT®FDL0951902023-01-31
00889858608459FlexiGRAFT®FGLTS08565FGLTS2018-08-01
00889858608466FlexiGRAFT®FGLTS08566FGLTS2018-08-01
00889858608473FlexiGRAFT®FGLTS08567FGLTS2018-08-01
00889858608480FlexiGRAFT®FGLTS08568FGLTS2018-08-01
00889858608497FlexiGRAFT®FGLTS08569FGLTS2018-08-01
00889858608503FlexiGRAFT®FGLTS08570FGLTS2018-08-01
00889858608510FlexiGRAFT®FGLTS08571FGLTS2018-08-01
00889858608527FlexiGRAFT®FGLTS08572FGLTS2018-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479283385McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283392McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283408McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283415McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285303McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285327McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285341McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285389McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285402McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285426McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285440McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285464McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285488McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285518McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285532McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285563McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285594McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285617McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285631McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285655McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285679McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285693McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
00840277412010ApeTapeRIVERPOINT MEDICAL, LLCGAT2026-05-22
00840277412027ApeTapeRIVERPOINT MEDICAL, LLCGAT2026-05-22
10810020085218HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411768HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411775HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411782HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411799HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
00840277411808HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16