PROCARE

GUDID 00190446155485

XCELTRAX AIR ANKLE, X-SMALL, HEALTH CARE EXP

DJO, LLC

Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis

• Primary Device ID: 00190446155485
• NIH Device Record Key: 4110418b-9940-4f8a-bed5-a51c27957fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROCARE
• Version Model Number: 79-95522-0213
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190446155485 [Primary]

FDA Product Code

• KNP: ORTHOSIS, CORRECTIVE SHOE

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: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [PROCARE]

• 00888912400312: 20" DELUXE UNIV KNEE IMMOB, CONTOURED, XL
• 00888912038317: PRE-VENT ULNAR NERVE PROT,18PR
• 00190446660552: KNEE IMMOBILIZER, XL 24 IN
• 00190446660538: KNEE IMMOBILIZER, XL 20 IN
• 00190446660521: KNEE IMMOBILIZER, XL 18 IN
• 00190446660514: KNEE IMMOBILIZER, UNIV 16 IN
• 00190446660507: KNEE IMMOBILIZER, UNIV 14 IN
• 00190446660491: KNEE IMMOBILIZER, UNIV 12 IN
• 00190446662723: SHOE, POST-OP SQ TOE XLG
• 00190446662716: SHOE, POST-OP SQ TOE LG
• 00190446662709: SHOE, POST-OP SQ TOE MED
• 00190446662693: SHOE, POST-OP SQ TOE SM
• 00190446660347: ARM SLING, CTN/POLY XLG
• 00190446660330: ARM SLING, CTN/POLY LG
• 00190446660323: ARM SLING, CTN/POLY MED
• 00190446660316: ARM SLING, CTN/POLY SM
• 00190446660309: ARM SLING, CTN/POLY XSM
• 00190446666004: MAXTRAX 2.0, AIR, ANKLE, XL
• 00190446665991: MAXTRAX 2.0, AIR, ANKLE, L
• 00190446665984: MAXTRAX 2.0, AIR, ANKLE, M
• 00190446665977: MAXTRAX 2.0, AIR, ANKLE, S
• 00190446665960: MAXTRAX 2.0, AIR, ANKLE, XS
• 00190446665953: MAXTRAX 2.0, AIR, TALL, XL
• 00190446665946: MAXTRAX 2.0, AIR, TALL, L
• 00190446665939: MAXTRAX 2.0, AIR, TALL, M
• 00190446665922: MAXTRAX 2.0, AIR, TALL, S
• 00190446665908: MAXTRAX 2.0, AIR, TALL, XS
• 00190446654360: MAXTRAX 2.0, STANDARD, ANKLE, XL
• 00190446654353: MAXTRAX 2.0, STANDARD, ANKLE, L
• 00190446654339: MAXTRAX 2.0, STANDARD, ANKLE, M
• 00190446654315: MAXTRAX 2.0, STANDARD, ANKLE, SM
• 00190446654308: MAXTRAX 2.0, STANDARD, ANKLE, XS
• 00190446654254: MAXTRAX 2.0, STANDARD, TALL, XL
• 00190446654247: MAXTRAX 2.0, STANDARD, TALL, L
• 00190446654223: MAXTRAX 2.0, STANDARD, TALL, M
• 00190446654209: MAXTRAX 2.0, STANDARD, TALL, SM
• 00190446654193: MAXTRAX 2.0, STANDARD, TALL, XS
• 00888912037648: ARM ELEVATION PILLOW
• 00888912027953: SILICONE HEEL CUP,XS,PAIR
• 00888912009874: LEG ELEVATOR, UNIV
• 00888912037365: SLIMLINE HIP ABDUC.PILLOW,UNIV
• 00888912037358: HIP ABDUCTION PILLOW,L
• 00888912037341: HIP ABDUCTION PILLOW,M
• 00888912037334: HIP ABDUCTION PILLOW,S
• 00888912393409: ADJ ALUM CRUTCH, LG, PAIR
• 00888912027335: 26" UNIV KNEE IMMOBILIZER W/LP LK
• 00888912027328: 22" UNIV KNEE IMMOBILIZER W/LP LK
• 00888912027311: 19" UNIV KNEE IMMOBILIZER W/LP LK
• 00888912027304: 14" UNIV KNEE IMMOBILIZER W/LP LK
• 00888912038508: WRAP LMB HLDR DBL XSTRNG,40 PR