Home GUDID 00191083047676 RapidEase™
Primary DI 00191083047676
Brand RapidEase™
Company Rti Surgical, Inc.
Model 4564SC
Catalog number 4564SC
Device description Quadruple Strand Pre-Sutured Tendon
Published 2023-11-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name GAT Suture, nonabsorbable, synthetic, polyethylene
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00191083047676 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00191083047676 00191083047676 191083047676 0191083047676
GMDN Terms# Term, Definition table Term Definition Tendon graft Processed (e.g., sterilised, aseptically processed) tendon tissue, harvested from a human donor, which may include a bone block, intended for transplantation to replace or strengthen damaged tendon. 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 Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 (-40C(-40F) or less to exp)
Regulatory Flags# DUNS number 117560455 Device count 1 DM exempt false Premarket exempt false HCT/P true Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number true 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 DI Brand Model Catalog Published 00191083045092 RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2cc ZR0302 001510Z 2024-05-27 00191083045108 RegenaVate™ Formable DBM RT, 1cc ZR0201 005301Z 2024-05-27 00191083045078 RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc ZR0305 001504Z 2024-05-27 00191083045085 RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1cc ZR0301 001505Z 2024-05-27 00191083045115 RegenaVate™ Formable DBM RT, 2cc ZR0202 005302Z 2024-05-27 10885862093196 OPTEFORM® Allograft Full Disc, 3 x 20mm, 1cc 002523 600-03-20 2015-11-06 10885862093202 OPTEFORM® Allograft Disc, 30mm x 3mm, 2cc 002530 600-03-30 2015-11-06 10885862093219 OPTEFORM® Allograft Disc, 45mm x 5mm, 8cc 002545 600-05-45 2015-11-06 10885862093226 OPTEFORM® Allograft Full Disc, 5 x 90mm, 32cc 002529 600-05-90 2015-11-06 10885862094094 OPTEFORM® Allograft Partial Disc, 75mm x 5mm, 15cc 002575 602-05-75 2015-11-06 10885862094100 OPTEFORM® Allograft Partial Disc, 90mm x 5mm, 22cc 002590 602-05-90 2015-11-06 10885862094223 OPTEFORM® Allograft Paste, 2cc 005102 606-01-02 2015-11-06 10885862094230 OPTEFORM® Allograft Paste, 5cc 005105 606-01-05 2015-11-06 10885862094247 OPTEFORM® Allograft Paste, 10cc 005110 606-01-10 2015-11-06 10885862094254 OPTEFORM® Allograft Paste, 20cc 005120 606-01-20 2015-11-06 10885862094384 OPTEFIL® Allograft Paste, 1cc 005001 616-01-01 2015-11-06 10885862094391 OPTEFIL® Allograft Paste, 5cc 005005 616-01-05 2015-11-06 10885862094407 OPTEFIL® Allograft Paste, 10cc 005010 616-01-10 2015-11-06 10885862094599 Synergent™ DBM, 1cc 004901 630-00-01 2015-11-06 10885862094605 Synergent™ DBM, 5cc 004905 630-00-05 2015-11-06
Other Devices Sharing Product Codes# 
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