RELI® VU489-M

GUDID 20386120010704

REDISORB PRO UND BR 6-0 YP-1 18"

MYCO MEDICAL SUPPLIES INC.

Polyester suture, bioabsorbable, multifilament

• Primary Device ID: 20386120010704
• NIH Device Record Key: 975e040d-e0b6-4766-a6d8-44b5c8576296
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELI®
• Version Model Number: VU489-M
• Catalog Number: VU489-M
• Company DUNS: 879187821
• Company Name: MYCO MEDICAL SUPPLIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended to be stored below 86°F (30°C), away from moisture and direct heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386120010700 [Primary]
GS1	10386120010707 [Package]; Contains: 00386120010700; Package: Inner Carton [12 Units]; In Commercial Distribution
GS1	20386120010704 [Package]; Contains: 10386120010707; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172659

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-21
• Device Publish Date: 2019-05-13

On-Brand Devices [RELI®]

• 20386120008909: Reli Gem Safety Blood Collection Set 23G x 3/4", 7" tubing
• 20386120008893: Reli Gem Safety Blood Collection Set 23G x 3/4", 3" tubing
• 20386120008886: Reli Gem Safety Blood Collection Set 21G x 3/4", 12" tubing
• 20386120008879: Reli Gem Safety Blood Collection Set 21G x 3/4", 7" tubing
• 20386120008862: Reli Gem Safety Blood Collection Set 25G x 3/4", 12" tubing with tube holder
• 20386120008855: Reli Gem Safety Blood Collection Set 25G x 3/4", 7" tubing with tube holder
• 20386120008848: Reli Gem Safety Blood Collection Set 25G x 3/4", 3" tubing with tube holder
• 20386120008831: Reli Gem Safety Blood Collection Set 23G x 3/4", 12" tubing with tube holder
• 20386120008824: Reli Gem Safety Blood Collection Set 23G x 3/4", 7" tubing with tube holder
• 20386120008817: Reli Gem Safety Blood Collection Set 23G x 3/4", 3" tubing with tube holder
• 20386120008800: Reli Gem Safety Blood Collection Set 21G x 3/4", 12" tubing with tube holder
• 20386120008794: Reli Gem Safety Blood Collection Set 21G x 3/4", 7" tubing with tube holder
• 20386120008787: Reli Gem Safety Blood Collection Set 21G x 3/4", 3" tubing
• 20386120008770: Reli Gem Safety Infusion Set 25G x 3/4", 12" tubing
• 20386120008763: Reli Gem Safety Infusion Set 25G x 3/4", 7" tubing
• 20386120008756: Reli Gem Safety Blood Collection Set 21G x 3/4", 3" tubing with tube holder
• 20386120008749: Reli Gem Safety Infusion Set 25G x 3/4", 3" tubing
• 20386120008732: Reli Gem Safety Infusion Set 23G x 3/4", 12" tubing
• 20386120008725: Reli Gem Safety Blood Collection Set 25G x 3/4", 12" tubing
• 20386120008718: Reli Gem Safety Infusion Set 23G x 3/4", 7" tubing
• 20386120008701: Reli Gem Safety Infusion Set 23G x 3/4", 3" tubing
• 20386120008695: Reli Gem Safety Blood Collection Set 25G x 3/4", 7" tubing
• 20386120008688: Reli Gem Safety Infusion Set 21G x 3/4", 12" tubing
• 20386120008671: Reli Gem Safety Blood Collection Set 25G x 3/4", 3" tubing
• 20386120008664: Reli Gem Safety Infusion Set 21G x 3/4", 7" tubing
• 20386120008657: Reli Gem Safety Infusion Set 21G x 3/4", 3" tubing
• 20386120008640: Reli Gem Safety Blood Collection Set 23G x 3/4", 12" tubing
• 20386120009371: RELI® Safety Blood Collection Needle 22G x 1.5”, Sterile
• 20386120009364: RELI® Safety Blood Collection Needle 22G x 1.25”, Sterile
• 20386120009357: RELI® Safety Blood Collection Needle 22G x 1”, Sterile
• 20386120009340: RELI® Safety Blood Collection Needle 21G x 1.5”, Sterile
• 20386120009333: RELI® Safety Blood Collection Needle 21G x 1.25”, Sterile
• 20386120009326: RELI® Safety Blood Collection Needle 21G x 1”, Sterile
• 20386120009319: RELI® Safety Blood Collection Needle 20G x 1.5”, Sterile
• 20386120009302: RELI® Safety Blood Collection Needle 20G x 1.25”, Sterile
• 20386120009296: RELI® Safety Blood Collection Needle 20G x 1”, Sterile
• 20386120010803: REDIGUT Plain Gut Suture 6-0 YG-1 18"
• 20386120010797: Introducer Needle 20G x 30mm, Sterile, 25/BX, 4BX/CS
• 30386120009460: RELI® Safety Blood Collection Needle 22G x 1.5”, Tube Holder attached, Sterile
• 30386120009453: RELI® Safety Blood Collection Needle 22G x 1.25”, Tube Holder attached, Sterile
• 30386120009446: RELI® Safety Blood Collection Needle 22G x 1”, Tube Holder attached, Sterile
• 30386120009439: RELI® Safety Blood Collection Needle 21G x 1.5”, Tube Holder attached, Sterile
• 30386120009422: RELI® Safety Blood Collection Needle 21G x 1.25”, Tube Holder attached, Sterile
• 30386120009415: RELI® Safety Blood Collection Needle 21G x 1”, Tube Holder attached, Sterile
• 30386120009408: RELI® Safety Blood Collection Needle 20G x 1.5”, Tube Holder attached, Sterile
• 30386120009392: RELI® Safety Blood Collection Needle 20G x 1.25”, Tube Holder attached, Sterile
• 30386120009385: RELI® Safety Blood Collection Needle 20G x 1”, Tube Holder attached, Sterile
• 20386120010780: REDICAPRONE-25 Monofilament Poliglecaprone 25, Violet, 0, MFSL, 36”
• 20386120010773: REDILON PRO BLK MF 10-0 YCS160-6 DA 12"
• 20386120010742: REDISORB PRO UND BR 5-0 YPS-2 18"