FDA.report

FlexiGRAFT®

Primary DI
00889858119511
Brand
FlexiGRAFT®
Company
LIFENET HEALTH
Model
FGL10075
Catalog number
FGL
Device description
GraftLink (10x75 MM)
Published
2015-09-24
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
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications

CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889858119511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889858119511008898581195118898581195110889858119511

GMDN Terms

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

TypeValueUnit
Length75Millimeter
Outer Diameter10Millimeter

Sterilization Methods

Method

Contacts

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

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00889858640831PliaFX FloBL-2200-05BL-2200-052025-01-01
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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
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00889858608473FlexiGRAFT®FGLTS08567FGLTS2018-08-01
00889858608480FlexiGRAFT®FGLTS08568FGLTS2018-08-01
00889858608497FlexiGRAFT®FGLTS08569FGLTS2018-08-01
00889858608503FlexiGRAFT®FGLTS08570FGLTS2018-08-01
00889858608510FlexiGRAFT®FGLTS08571FGLTS2018-08-01
00889858608527FlexiGRAFT®FGLTS08572FGLTS2018-08-01

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