PRO-DENSE™

GUDID 00889797073301

WRIGHT MEDICAL TECHNOLOGY, INC.

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID00889797073301
NIH Device Record Key8f82fb03-108b-4c93-8d07-1e03eaeddf6f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRO-DENSE™
Version Model Number87SR0070
Company DUNS807201207
Company NameWRIGHT MEDICAL TECHNOLOGY, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com

Device Dimensions

Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]
GS100889797073301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND
MQVFILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [PRO-DENSE™]

008897970727311200SYR0
0088979707331887SR0120
0088979707330187SR0070
0088979707276287SR0100
0088979707275587SR0050
0088979707274887SR0020
0088979707272487SRCDK0
0088979707271787SR0400
0088979707270087SR0150

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