RELI R-BEN1110

GUDID 10386120008070

BEN® Bone marrow biopsy needle, Trocar point, 11G x 10cm

MYCO MEDICAL SUPPLIES INC.

Bone marrow biopsy procedure kit

• Primary Device ID: 10386120008070
• NIH Device Record Key: 5491d6bd-54e3-478a-9509-1f89ec24e103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELI
• Version Model Number: R-BEN1110
• Catalog Number: R-BEN1110
• Company DUNS: 879187821
• Company Name: MYCO MEDICAL SUPPLIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge
• Length: 10 Centimeter
• Needle Gauge: 11 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386120008073 [Primary]
GS1	10386120008070 [Package]; Contains: 00386120008073; Package: Inner Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051506

FDA Product Code

• KNW: Instrument, Biopsy

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: 2018-10-12
• Device Publish Date: 2018-09-11

On-Brand Devices [RELI]

• 00386120008615: MULTICORE® Automatic guillotine type instrument for soft tissue biopsy, 14G x 15cm
• 10386120008605: MAMMOREP N® Breast localization needle, simple hook-wire 21G x 15cm
• 10386120008599: MAMMOREP N® Breast localization needle, simple hook-wire 21G x 11cm
• 10386120008582: MAMMOREP N® Breast localization needle, simple hook-wire 21G x 9cm
• 10386120008575: MAMMOREP N® Breast localization needle, simple hook-wire 21G x 6cm
• 10386120008148: MULTICORE® Automatic guillotine type instrument for soft tissue biopsy, 18G x 25cm
• 10386120008131: MULTICORE® Automatic guillotine type instrument for soft tissue biopsy, 18G x 20cm
• 10386120008124: MULTICORE® Automatic guillotine type instrument for soft tissue biopsy, 14G x 11cm
• 10386120008117: MIELO-CAN® Bone marrow biopsy needle, 15G, 0.86" - 1.57" max 2.36"
• 10386120008100: FAST-CUT B® Biopsy needle for automatic gun, 18G x 25cm
• 10386120008094: FAST-CUT B® Biopsy needle for automatic gun, 18G x 20cm
• 10386120008087: COLT® Automatic guillotine type instrument for soft tissue biopsy, 14G x 11cm
• 10386120008070: BEN® Bone marrow biopsy needle, Trocar point, 11G x 10cm
• 00386120008066: AGO GUIDA® Guide Needle for COLT, 13G x 2.85"
• 20386120007933: REDISORB Undyed Braided & Coated Polyglycolic Acid 4-0 MFS-1 27"
• 20386120007926: REDISORB Undyed Braided & Coated Polyglycolic Acid 3-0 YPS-2 18"
• 20386120007919: REDISORB Undyed Braided & Coated Polyglycolic Acid 4-0 YPS-2 18"
• 20386120007902: REDISORB Undyed Braided & Coated Polyglycolic Acid 4-0 YP-3 18"
• 20386120007896: REDISORB Undyed Braided & Coated Polyglycolic Acid 5-0 YP-3 18"
• 20386120007889: REDISORB Undyed Braided & Coated Polyglycolic Acid 6-0 YP-3 18"
• 20386120007872: REDISORB Undyed Braided & Coated Polyglycolic Acid 4-0 YFS-2 27"
• 20386120007865: REDISORB Undyed Braided & Coated Polyglycolic Acid 3-0 YSH 27"
• 20386120007858: REDIBOND Coated Polyester 5-0 YRB-1 DA 36"
• 20386120007841: REDILENE Monofilament Polypropylene 4-0 YP-3 18"
• 20386120007834: REDILENE Monofilament Polypropylene 5-0 YP-3 18",
• 20386120007827: REDILENE Monofilament Polypropylene 6-0 YP-1 18"
• 20386120007810: REDILENE Monofilament Polypropylene 6-0 YP-3 18",
• 20386120007803: REDILENE Monofilament Polypropylene 3-0 YPS-2 18"
• 20386120007797: REDILENE Monofilament Polypropylene 5-0 YPS-2 18"
• 20386120007780: REDILENE Monofilament Polypropylene 4-0 YFS-2 18"
• 20386120007773: REDILENE Monofilament Polypropylene 4-0 YPS-2 18"
• 20386120007766: REDILENE Monofilament Polypropylene 3-0 YFS-2 18"
• 20386120007759: REDILENE Monofilament Polypropylene 5-0 YRB-1 DA 36"
• 20386120007728: REDILON Monofilament Polyamide (Nylon) 4-0 YC-2 10"
• 20386120007711: REDILON Monofilament Polyamide (Nylon) 4-0 YP-3 18"
• 20386120007704: REDILON Monofilament Polyamide (Nylon) 5-0 YP-3 18"
• 20386120007698: REDILON Monofilament Polyamide (Nylon) 6-0 YP-1 18"
• 20386120007681: REDILON Monofilament Polyamide (Nylon) 5-0 YC-2 10"
• 20386120007674: REDILON Monofilament Polyamide (Nylon) 3-0 YFS-1 18"
• 20386120007667: REDILON Monofilament Polyamide (Nylon) 4-0 YFS-2 18"
• 20386120007643: REDILON Monofilament Polyamide (Nylon)4-0 YFS-2 10"
• 20386120007636: REDILON Monofilament Polyamide (Nylon) 5-0 YFS-2 18"
• 20386120007629: REDILON Monofilament Polyamide (Nylon) 6-0 YP-3 18"
• 20386120007612: REDILON Monofilament Polyamide (Nylon) 4-0 YPS-2 18"
• 20386120007605: REDILON Monofilament Polyamide (Nylon) 5-0 YPS-2 18"
• 20386120007599: REDILON Monofilament Polyamide (Nylon) 3-0 YPS-1 18"
• 20386120007582: REDICAPRONE-25 Monofilament Poliglecaprone 25 Undyed Braided 3-0 YPS-1 27"
• 20386120007575: REDICAPRONE-25 Monofilament Poliglecaprone 25 Undyed Braided 3-0 YPS-2 18"
• 20386120007568: REDICAPRONE-25 Monofilament Poliglecaprone 25 Undyed Braided 4-0 YPS-2 18"
• 20386120007551: REDICAPRONE-25 Monofilament Poliglecaprone 25 Undyed Braided 5-0 YPS-2 18"