Speedlock

GUDID 00848657084369

Speedlock Kerrison 3mm Cervical Custom

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Bone punch, reusable

• Primary Device ID: 00848657084369
• NIH Device Record Key: ffea0d97-fa64-4623-a0df-5a4ef318785f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speedlock
• Version Model Number: 8560-07
• Company DUNS: 839138955
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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	00848657084369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023868

FDA Product Code

• HAE: RONGEUR, MANUAL

Sterilization

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

[00848657084369]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-26

On-Brand Devices [Speedlock]

• 00848657086509: Speedlock Maryland, 5mm, Cross Serrations NON Modular
• 00848657086493: Speedlock Fenestrated Clamp, 5mm, with Ratchet NON Modular
• 00848657086486: Speedlock Maryland, 5mm, Cross Serrations with Ratchet NON Modular
• 00848657086448: Speedlock Large Spoon Forceps, 10mm, 26cm Insert
• 00848657086370: Speedlock Glassman Clamp,10mm with Ratchet, 26cm Length, 60mm Jaw, Handle D1368 Composite On/Off
• 00848657085960: Speedlock Atraumatic Clamp, 5mm, only cross serrated 26cm Insert
• 00848657084826: Speedlock Bowel Grasper 5mm 33cm
• 00848657084635: Speedlock Allis Atraumatic Clamp, 5mm, TC inserts, 26cm Insert
• 00848657084369: Speedlock Kerrison 3mm Cervical Custom
• 00848657084017: Speedlock Fenestrated Dissector, 5mm w/ Ratchet w/ Standard Composite Handle
• 00848657083539: Speedlock Tenaculum Forcep 5mm, 33cm
• 00848657074377: Speedlock Hook Scissors, 5mm, 45cm
• 00848657074346: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 45cm Length, Handle D136
• 00848657074339: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 45cm Length, Handle 8511
• 00848657074322: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 45cm Length, Handle 8511
• 00848657074315: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 45cm Length, Handle 8510
• 00848657074308: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 45cm Length, Handle 8510
• 00848657074292: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 45cm Length, Handle 1362
• 00848657074285: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 45cm Length, Handle 1358
• 00848657074278: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 34cm Length, Handle D136
• 00848657074261: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 34cm Length, Handle 8511
• 00848657074254: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 34cm Length, Handle 8511
• 00848657074247: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 34cm Length, Handle 8510
• 00848657074230: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 34cm Length, Handle 8510
• 00848657074223: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 34cm Length, Handle 1362
• 00848657074216: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 34cm Length, Handle 1358
• 00848657074209: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 30cm Length, Handle D136
• 00848657074193: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 30cm Length, Handle 8511
• 00848657074186: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 30cm Length, Handle 8511
• 00848657074179: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 30cm Length, Handle 8510
• 00848657074162: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 30cm Length, Handle 8510
• 00848657074155: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 30cm Length, Handle 1362
• 00848657074148: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 30cm Length, Handle 1358
• 00848657074131: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 26cm Length, Handle D136
• 00848657074124: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 26cm Length, Handle 8511
• 00848657074117: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 26cm Length, Handle 8511
• 00848657074100: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 26cm Length, Handle 8510
• 00848657074094: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 26cm Length, Handle 8510
• 00848657074087: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 26cm Length, Handle 1362
• 00848657074070: Speedlock Needle Holder, 5mm, Tapered Jaw with TC Inserts with Ratchet, 26cm Length, Handle 1358
• 00848657074063: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 45cm Length, Handle D
• 00848657074056: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 45cm Length, Handle 8
• 00848657074049: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 45cm Length, Handle 8
• 00848657074032: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 45cm Length, Handle 8
• 00848657074025: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 45cm Length, Handle 8
• 00848657074018: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 45cm Length, Handle 1
• 00848657074001: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 45cm Length, Handle 1
• 00848657073998: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 34cm Length, Handle D
• 00848657073981: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 34cm Length, Handle 8
• 00848657073974: Speedlock Needle Holder Pointed Version, 5mm, 8mm Jaw Length with Ratchet, 34cm Length, Handle 8