X-RepairSL Z020-80SL

GUDID B05502080

X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 80mm (WxL)

SYNTHASOME, INC.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device IDB05502080
NIH Device Record Key6bdb2664-f1de-430b-9a1b-c8b90d0ad2c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-RepairSL
Version Model NumberZ020-80SL
Catalog NumberZ020-80SL
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
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com

Device Dimensions

Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter
Width4 Millimeter
Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB05502080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-01
Device Publish Date2023-07-24

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)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.