DONJOY

GUDID 00888912007535

ARCH RIVAL, D

DJO, LLC

Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis

• Primary Device ID: 00888912007535
• NIH Device Record Key: ea723891-8835-45d2-a3c2-736589a3d756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DONJOY
• Version Model Number: 11-2015-4
• Company DUNS: 081840873
• Company Name: DJO, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888912007535 [Primary]

FDA Product Code

• KYS: INSOLES, MEDICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-31
• Device Publish Date: 2022-05-23

On-Brand Devices [DONJOY]

• 00190446286974: X4 KNEE BRACE, LT, UNIV, BLK
• 00190446286967: X4 KNEE BRACE, RT, UNIV, BLK
• 00190446257189: DONJOY ICEMAN CLEARCUBE
• 00190446220312: DONJOY ICEMAN CLEARCUBE, K. PERMANENTE
• 00888912300070: VQ,COLD THERAPY SYSTEM
• 00888912218146: ICEMAN CLEARCUBE W/UNIV WRAP-ON PAD, NS, RH, INT'L
• 00888912215824: ICEMAN, INT'L, MODEL 2400
• 00888912205160: DONJOY ROM KNEE W/UNIT
• 00888912161619: ICEMAN W/,RECT,STERILE,EH,XL
• 00888912158046: PAD, ELBOW, MANUAL COLD
• 00888912157766: ICEMAN CLEARCUBE W/ANKLE WRAP-ON PAD, NS, RH
• 00888912153904: COLD WRAP,SHOULDER,S-M
• 00888912153027: COLD WRAP,BACK,L-XL
• 00888912018098: ICEMAN CLEARCUBE W/MCGUIRE KNEE WRAP-ON PAD, NS, RH
• 00888912018081: ICEMAN CLEARCUBE W/SHOULDER, S WRAP-ON PAD, NS, RH
• 00888912018074: ICEMAN CLEARCUBE W/UNIV WRAP ON PAD, NS, EH
• 00888912018067: ICEMAN CLEARCUBE W/UNIV WRAP ON PAD, NS, RH
• 00888912018050: ICEMAN CLEARCUBE W/UNIV COLD PAD, NS, RH
• 00888912018043: ICEMAN CLEARCUBE W/UNIV COLD PAD, S, RH
• 00888912017312: ICEMAN W/,UNIV,STERILE,EH
• 00888912017305: ICEMAN W/,UNIV,LOOP,NS,EH
• 00888912017299: ICEMAN W/,UNIV,NS,RH
• 00888912017282: ICEMAN W/,UNIV,STERILE,RH
• 00888912017015: DRESSING,WO SHOULDER,STERILE
• 00888912016599: PAD, ANKLE, MANUAL COLD
• 00888912016582: PAD, KNEE, MANUAL COLD
• 00888912016575: PAD, SHOULDER, MANUAL COLD
• 00888912016384: COLD PAD, WRIST, FOAM, S, SH
• 00888912015349: COLD PAD,SM RECT,FOAM,S,RH
• 00888912015332: COLD PAD,ANKLE FOAM,S,RH
• 00888912015325: COLD PAD,UNIV,FOAM,S,EH,XL
• 00888912015318: COLD PAD,UNIV FOAM,S,EH
• 00888912014878: COLD WRAP,SHOULDER,L-XL
• 00888912006675: ICEMAN, ANKLE COLD PAD
• 00888912006668: ICEMAN, FOREFOOT COLD PAD
• 00888912005869: ICEMAN W/,UNIV,LOOP,NS,RH
• 00888912005845: COLD PAD,SHOULDER,S,LOOP,EH,NS
• 00888912005654: COLD PAD, SHOULDER, LOOP, NS
• 00888912005456: COLD PAD,MCGUIRE,LOOP,NS,RH
• 00888912003940: COLD PAD,RECT,FOAM,S,EH,XL
• 00888912003933: COLD PAD,UNIV,FOAM,S,RH
• 00888912003650: COLD PAD,UNIV LOOP,NS,EH,XL
• 00888912003643: COLD PAD,UNIV LOOP,NS,RH,XL
• 00888912003636: COLD PAD,UNIV LOOP,NS,EH
• 00888912003629: COLD PAD,UNIV,LOOP,NS,RH
• 00888912003612: COLD PAD,UNIV,FOAM,NS,EH,XL
• 00888912003605: COLD PAD,UNIV FOAM,NS,EH
• 00888912003599: COLD PAD,UNIV,FOAM,NS,RH
• 00888912003582: DUAL PAD CONNECTOR
• 00888912003414: COLD WRAP,KNEE/THIGH