FDA.reportPublic FDA data

CoPilot VL Disposable Sheaths, Slim, Size 3

Primary DI
00810049840143
Brand
CoPilot VL Disposable Sheaths, Slim, Size 3
Company
Dilon Technologies, Inc.
Model
3650-S
Catalog number
3650-S
Device description
CoPilot VL Disposable Sheaths, Slim, Size 3
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810049840089PackageGS110In Commercial Distribution
00810049840143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004984008910810049840089
00810049840143008100498401438100498401430810049840143

GMDN Terms#

Term, Definition table
TermDefinition
Video intubation laryngoscope kitA collection of video laryngoscopic devices intended to be used for various procedures on the airway and respiratory tract including intubation, lung dual-chamber positioning, suction, biopsy, drug administration and oxygen giving. It typically consists of a set of video intubation laryngoscope blades, a video intubation laryngoscope handle/monitor, a rigid non-bladed video intubation laryngoscope and a flexible video intubation laryngoscope.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061727272
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810049840010CoPilot VL Disposable Sheaths Size 1, Box of 10371037102022-12-08
10810049840027CoPilot VL Disposable Sheaths, Size 2 Case of 10372037202022-12-08
10810049840034CoPilot VL Disposable Sheaths, Size 3373037302022-12-08
00810049840006Navigator 2.0 Control Unit2.0N2-9800-002022-12-08
00810049840020Navigator Laparoscopic Probe, 10mm Wired SP-2S10-31SP-2S10-312022-12-08
00810049840037Navigator Daniel Lung Probe, 10mm Wired SP-2S10-31DSP-2S10-31D2022-12-08
00810049840044Navigator Superficial Head & Neck Probe, 11mm WiredSP-2S11-53SP-2S11-532022-12-08
00810049840051Navigator Standard Lymphactic Mapping Probe, 14mm, Wired, AngledSP-2A14-67SP-2A14-672022-12-08
00810049840068Navigator Standard Lymphactic Mapping Probe, 14mm, Wired, StraightSP-2S14-67SP-2S14-672022-12-08
00810049840075Navigator Wireless Probe, 14mm AngledWP-9000-14WP-9000-142022-12-08
00810049840082Navigator Wireless Probe, 14mm StraightWP-9000-14SWP-9000-14S2022-12-08
01810049840012CoPilot VL Disposable Sheaths Size 1, Box of 10371037102022-12-08
01810049840029CoPilot VL Disposable Sheaths, Size 2 Case of 10372037202022-12-08
01810049840036CoPilot VL Disposable Sheaths, Size 3373037302022-12-08
00810049840099CoPilot VL Disposable Sheaths, Size 1361036102022-12-07
00810049840105CoPilot VL Disposable Sheaths, Size 2362036202022-12-07
00810049840112CoPilot VL Disposable Sheaths, Size 3363036302022-12-07
00810049840129CoPilot VL Disposable Sheaths, Slim, Size 43640-S3640-S2022-12-07
00810049840136CoPilot VL Disposable Sheaths, Size 5365036502022-12-07
00810049840150CoPilot VL Disposable Sheaths, Slim, Size 33630-S3630-S2022-12-07

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Primary DI, Brand, Company table
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06971355350178BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
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