X-RepairSL

GUDID B05502280SL

X-RepairSL, Bioabsorbable surgical mesh, single layer, 12mm x 80mm (WxL)

SYNTHASOME, INC.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable
Primary Device IDB05502280SL
NIH Device Record Key5a7f8f6a-dce0-474f-9def-719412abe332
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-RepairSL
Version Model NumberZ022-80SL
Company DUNS140697280
Company NameSYNTHASOME, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx

Device Dimensions

Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter
Length80 Millimeter
Width12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB05502280SL [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-13

On-Brand Devices [X-RepairSL]

B05502480SLX-RepairSL, bioabsorbable surgical mesh, single-layer, 25mm x 80mm (WxL)
B05502280SLX-RepairSL, Bioabsorbable surgical mesh, single layer, 12mm x 80mm (WxL)
B055021160SLX-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 160mm (WxL)
B055020160SLX‐RepairSL, Bioabsorbable surgical mesh, single‐layer 4mm x 160mm (WxL)
B05502180X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 80mm (WxL)
B05502120X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 20mm (WxL)
B05502080X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 80mm (WxL)
B05502020X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 20mm (WxL)

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