HEALICOIL REGENESORB 72203697

GUDID 00885554031393

HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE COBRAID BLUE AND ONE ULTRABRAID SUTURE No.2

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable
Primary Device ID00885554031393
NIH Device Record Key114ceae3-204c-430f-9980-01aac3a746b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALICOIL REGENESORB
Version Model Number72203697
Catalog Number72203697
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100885554031393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, fixation, biodegradable, soft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-16
Device Publish Date2021-12-08

On-Brand Devices [HEALICOIL REGENESORB]

00885554031430HEALICOIL REGENESORB 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE
00885554031423HEALICOIL REGENESORB 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE
00885554031409HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAP
00885554031393HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAP

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